Quality Associate Resume Samples

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J Cummings

Jennie

Cummings

154 Auer Lights

San Francisco

+1 (555) 148 5579

154 Auer Lights

San Francisco

Phone

p +1 (555) 148 5579

Experience Experience

New York, NY

Quality Associate

New York, NY

Rohan-Moen

New York, NY

Quality Associate

Will assist the Quality Manager with all quality operations and responsibilities at the Pain Management facility
Perform ad-hoc duties as requested by line management
You work as a tester in an agile development team
Create, review and modify standard work instructions
Assist with and perform validations and change controls for equipment, procedure, and process changes
Assist the Center Quality Manager to ensure that cGMP regulations are followed
Provide support to operations on the shop floor with relation to process improvement and error reduction

Phoenix, AZ

R&D Quality Associate

Phoenix, AZ

Volkman-Swift

Phoenix, AZ

R&D Quality Associate

Monthly reporting of key quality performance indicators for management review
Completes risk assessments on vendor management activities
Assists in the investigation and resolution of system deviations and clinical trial breaches
Assists in the assessment of GCP quality system documentation such as change controls and quality SOPs
Ensures that the quality assurance system is established, implemented, maintained and monitored in accordance with relevant standards
Is actively involved in the preparation for and the management of inspections by regulatory authorities
Provides GCP training to R&D employees

present

Boston, MA

Senior Quality Associate

Boston, MA

Schumm, Armstrong and Fritsch

present

Boston, MA

Senior Quality Associate

present

Serving as a liaison between the call evaluation vendors and Travel Operations by facilitating calibration between Travel Operations leaders and vendors for Trust and Quality Monitoring assessments to ensure call review accuracy. Further, the role reviews disputes and delivers information and feedback to the vendor for further assessment and communicates the outcomes to the Travel Ops leaders
Checking of defined critical process steps during production
Performing tasks allowing the release of the Sanquin products
Providing technical advice to Production areas on GMP and Quality related issues
Creating weekly and monthly Agent performance (Quality Monitoring and Trust metrics) reports leveraged by all levels of Travel Operations leadership for trending and coaching purposes. Moving forward this person will aid in building more dynamic reports for ease of access and use
Trigger continuous improvement of routine processes defined with CMO
Ensure quality of methods, processes, materials and products by providing coordination and review of group operations, staff training, and the assessment/improvement of systems and processes

Education Education

Bachelor’s Degree in Science

West Virginia University

Bachelor’s Degree in Science

Skills Skills

Excellent team player with a strong ability to network and with drive for tangible results
4) Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
Strong analytical skills, as well as excellent interpersonal and communication skills
Strong willingness and ability to learn
Excellent communication skills in English and German, ability to interact with team members, project leads and developers in a global work environment
Very good assertiveness to secure that our software achieves the highest quality standards
Willingness and ability to learn new subjects quickly
Sound industry knowledge, project proficiency, and autonomy expected. May be considered a Subject Matter Expert (SME) in various disciplines
Constructive Quality Assurance (Quality Risk Assessment, Test Strategy & Design, Test Process, Test Methodology, Test Tool Evaluation & Development)
Strong background of SAP Quality processes, Testing, Automation

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15 Quality Associate resume templates

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Assessment of Service Quality Associate Director Resume Examples & Samples

Create and define ASQ strategy, focus and direction for the Sub-Area and confirm these with leaders. Review and identify resource needs to accomplish Sub-Area ASQ balanced scorecard goals
Identify the sub-Area's ASQ target clients for the current fiscal year, based on revenue, strategic relationships, risk factors and ASQ history. Determine the appropriate Area leaders to conduct the dialogue
Help individual accounts to develop ASQ strategy and plans
Working with client executives and audit committees, serve as a primary Sub-Area interviewer for the Sub-Area's priority accounts, focusing on top revenue clients, Office of the Chair Accounts (OCA) and Strategic Growth Market (SGM) clients. Prepare objective reviews of client assessments of our service quality
Use your superior discovery skills to probe deeper into client responses, to obtain objective and accurate results
Discuss dialogue results with and make recommendations to the Client Service Partner and teams
Follow up Sub-Area ASQ results to fully address client feedback. Recommend service strategies based on this feedback
Identify relationship risks and escalate issues to Sub-Area leaders to mitigate client loss
Analyze Sub-Area-wide results and identify service quality trends. Produce quantitative and qualitative reports and recommend actions for the professional practice group, industry and office
Provide dialogue insights to the pursuit team and Business Development leaders
Regularly present Sub-Area leaders with ASQ key findings, coverage metrics and trends that impact quality
Monitor progress towards ASQ balanced scorecard goals
Build and execute a marketing and communications plan for ASQ activities and achievements
Lead and coach the ASQ Coordinator and/or ASQ Manager
Team with other Sub-Area ASQ resources, as appropriate
Interface directly with C-suite executives and respond appropriately to problems or issues raised
Research and analyze trends and systemic issues and suggest how to use the data
Gain a strong knowledge of Ernst & Young's services, client satisfaction trends and insights
Create/maintain a high performance, results-oriented environment
Create an environment for providing quality service to customers. Advise and provide input to senior leaders on customer issues
Communicate with and influence the firm's senior managers and leaders
Create an environment of continuous improvement and innovation. Think creatively and provide innovative suggestions for improving service quality
Develop and maintain effective working relationships with senior firm leaders. Create an environment that promotes effective teamwork and collaboration
Make decisions and overcome obstacles in consultation with ASQ resources and Sub-Area leaders
Supervise the Sub-Area ASQ team, notably the coordinator and/or manager
A strong executive presence, including the ability to interact with all levels of management including CEO/CFO level
Demonstrated business acumen and understanding of external marketplace factors
Strong interviewing skills
High-level influencing skills
Excellent oral presentation ability
Ability to complete multiple tasks in a fast-paced environment
A minimum of 20 years complex client relationship, client sales, business development and/or market-facing experience

Quality Associate Resume Examples & Samples

Support the quality manager in the maintenance of a compliant quality system in the Limerick site
Maintain equipment calibration schedule and records
Maintain control of quality documentation
Work with the operations team to ensure the release of compliant product
Write and maintain quality standards and procedures
Support training of staff on applicable standards and procedures
Perform duties in accordance with BD policies & procedures & GMP regulations
A minimum of 2 years' quality experience in a production or R&D industry
Knowledge of cGMP (Good Manufacturing Practice)
Should possess good documentation and effective communication skills
Good knowledge of PC spreadsheet, word processing, and database applications
Must be able to work independently within a team-oriented environment
SAP experience may be beneficial
Requires a demonstrated ability to follow established policies and procedures

Quality Associate Resume Examples & Samples

Understand the business requirements and create test strategy, test plans & detailed test scenarios to test the business requirements
Perform system testing of new applications and software enhancements to existing applications and ensure they meet design specifications
Develop automated tests using JBehave & Selenium early in development cycle so that defects are caught and addressed in a timely manner
To assist in Regression Testing of new applications and existing software enhancements to identify any possible impacts caused by changes
Liaise with production Owners and development team to explain the defects and priorities of the defects
Proactively participate in peer reviews either as reviewer or an author being reviewed with the aim to enhance own or team member’s work and standards

Senior Quality Associate Resume Examples & Samples

5-7 years of related experience
Prior experience in Quality Assurance
CAPA system experience

Transaction Quality Associate Resume Examples & Samples

Conducts audits and reviews/analyzes data and documentation
Uses the organization's resources to enhance customer satisfaction
Ensures that data and information are sufficiently accurate and reliable
Alternate from Web Research
Performs call monitoring and provides trend data to site management team
Uses quality monitoring data management system to compile and track performance at team and individual level
Provides actionable data to various internal support groups as needed
Prepares and analyzes internal and external quality reports for management staff review

Quality Associate Manager Resume Examples & Samples

Lead a team of 10-15 Quality professionals to include coaching, talent development, performance management, and Supervision of Quality professionals who are Series 6 Registered Representatives
Identify and share best practices, strengthen talent and explore process improvements
Work across the organization to define, analyze, improve and sustain business performance solutions that meet or exceed Business Partner expectations
Create a continuous improvement culture fostered by change management and built on leadership capability
Identify opportunities to prevent or eliminate the opportunity for defects/errors in a process
Enable Business Partners to successfully process work accurately, timely, completely and in compliance with rules and procedures
Develop and lead with an end-to-end Quality mindset
Prior leadership experience across multiple sites and/or business units preferred
Proven ability to manage virtual teams
Strong relationship management, leadership and influence skills
Familiarity with financial/insurance operations
Contact Center experience a plus
Ability to work with diverse business cultures and perspectives to build a collaborative, high performing team
Demonstrated critical thinking, problem solving, decision making and analytical skills
External focus and understanding of customer needs, expectations and industry best practices
Microsoft Office proficiency (i.e. Word, Power Point, Excel)
Location flexible
Series 6 and Series 26 registration required or needs to obtained within 120 days of hire

Quality Associate Resume Examples & Samples

High level of Analytical & Presentation Skills
Good command on MS Excel & excellent communication skills are required for this role
Should have a good understanding of Quality Process and should have been exposed to working on Analysis Techniques and Tools
Good Knowledge of MS office and Macros preferred

Quality Associate Resume Examples & Samples

Will assist the Quality Manager in conducting internal audits of processes, systems and procedures
Will participate in cross-functional teams to identify effective corrective and preventive actions to improve process quality
Daily activities will include but not limited to: pooling, subassembly and final batch processing, label and packing, environmental monitoring, training of specific procedures
Conduct root cause analysis for compounding errors and in-process errors generated at the Memphis facility during all phases of the production process
Will assist Quality Manager in assuring the timely closure of incident complaints
Write, review and revise SOP’s as needed to assure compliance and continuous improvement
Will coordinate and schedule testing of all product for the on-going stability and on-going sterility monitoring programs with the appropriate contract labs (ensure product is produced and shipped to the appropriate lab in a timely manner)
Will perform review of quality related documents generated at the Cleveland facility

Quality Associate Resume Examples & Samples

Lead/support ongoing, daily customer complaints operations to complete complaint evaluations on time
Support or lead the complaint reduction projects
Perform in-depth internal investigations and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques. Work closely with production supervisors, quality, engineering and other internal groups to accomplish the above and influence necessary actions. Determine the logic, adequacy and effectiveness of processes, systems and related requirements. Develop plans to correct identified risks including areas of non-conformance. Inform management and implement approved corrective action plans
Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements. Provide training and coaching to local employees and others as needed on relevant area(s). When required, assist other Quality areas in the successful performance of these activities
Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc
Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills. Support process with timely closure of observations/audit items
Participate in QA/QC projects in the role of contributor, coordinator or lead
Other duties, tasks or projects as assigned
Experience working in a GMP environment; working knowledge of Medical Device regulations including ISO 13485 and 21 CFR 820
Demonstrated success in delivering results on several technical challenges. Strong ability to work in ambiguity and simplify the complex into operational processes with sustainable results
Strong interpersonal skills and great attention to detail are necessary. Must be a strong team player with good problem solving, and good verbal and written communication skills. Must have the ability to manage people, encourage teamwork and drive decisions
Extensive cross-functional team experience, including technical and non-technical work
Ability to organize and present technical and project mgt. overviews without assistance. Must be able to handle multiple projects concurrently
Proficiency in Microsoft Word, Project, and Excel, computer software. Trackwise 8 knowledge is plus
Ability to execute routine tasks timely, accurately. Ability to prioritize multiple tasks
BS in science or engineering
3-5 year experience with a medical device or pharma company, qualifty experience preferred

Quality Associate Resume Examples & Samples

Coordinate and execute cGMP stability studies. Participate in the development of stability study protocols for new pharmaceutical products and existing products with speed, accuracy, and consistency to meet quality drug development goals
Coordinate activities of outside work groups and monitor stability study progress to ensure timely and effective completion. Responsible for preparing Stability updates and Annual Reports to FDA
Participate on project teams and/or interact with various functions within Baxter in order to provide technical support and assistance. Proactively provide guidance regarding study set-up specifications, processes and timelines
Maintain knowledge of relevant Quality System Regulations, high level of expertise in current regulatory requirements and technical issues as related to R&D (product development, design and safety) and serve as a resource for compliance to the requirements to ensure compliance in all research, data collection and reporting activities. Active participation in the generation, review, adoption and interpretation of such regulations
Aid in exploring innovative approaches to processes and technologies. Responsible for identifying improvements in metrics and leads process improvements. Maintain and own internal documents. Write, revise and review SOPs
Assist in training less experienced staff as needed. Assist and write requirements for product changes and computer systems. Perform/assist in internal assessments by collecting and analyzing accurate, objective evidence regarding quality risks and their magnitude
Lead ongoing daily departmental activities for areas of direct responsibility including supervision of assigned personnel, and when required assist other Quality areas in the successful performance of these activities
Be directly involved in and where appropriate lead multiple process/product improvement projects which may include any of the following – PMT, Kaizan, or other focus groups, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation
Must be recognized by all levels of the facility as an expert in their area and be able to demonstrate leadership ability. Must have the ability to perform the responsibilities of the Manager on an as needed basis

Quality Associate Resume Examples & Samples

1) Lead ongoing daily departmental activities for areas of direct responsibility including supervision of assigned personnel, and when required assist other Quality areas in the successful performance of these activities
2) Manage activities of self and direct reports in achieving defined quality goals in an efficient, accurate and timely manner
3) Be directly involved in and where appropriate lead multiple process/product improvement projects which may include any of the following - Kaizen and VSM, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation
4) Lead in-plant audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Baxter quality requirements. Maintain a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements
5) Lead in the development of customer awareness and understanding activities for areas of direct responsibility, and where appropriate, assist and support such activities throughout the facility
6) Provide guidance and coaching for the areas of responsibility
7) Must be a recognized by all levels of the facility as an expert in their area and be able to demonstrate leadership ability
8) Must have the ability to perform the responsibilities of the Quality Section Manager on an as needed basis
9) Assists and writes validations for equipment, product changes and computer systems
10) Assists with vendor audits/assessments and provides ongoing feedback related to quality issues
1) Understand scientific strategies and be able to invent new methods or new avenues of investigation
2) Good interpersonal/communication/influencing/negation skills
3) Good project management skills
4) Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
5) Bachelor's degree in science or engineering; advanced degree in the life sciences, physical sciences or engineering, with Ph.D. is ideal
) Minimum of 5-8 years of experience in Quality, or related field in the medical products industry

Quality Associate Resume Examples & Samples

Leads cross-functional team in development and maintenance of plant RBLCM Playbooks
Collects, analyzes and reports RBLCM performance data
Manage project schedules in achieving defined quality goals in an efficient, accurate and timely manner
Directly involved in and, where appropriate, leads multiple process/product improvement projects which may include any of the following – CAPA Investigations, Kaizan Teams, Change Control Projects, equipment/process validations, development of new procedures and improving existing procedures, data collection and analysis, report development and presentation
Conduct line audits on routine basis working directly with production personnel in manufacturing areas
Maintains a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements. Maintains audit ready status for assigned areas and assists other areas within the facility in maintaining compliance with local procedures as well as US & International Regulatory and Baxter corporate quality requirements
Perform, review, and approve nonconformance Nonconformance CAPA investigations within the TW8-CAPA system
Perform trending analysis and manufacturing assessments within the customer complaint system
Provide guidance and coaching on performance of DMAIC problem solving and process improvement projects for less experienced individuals within the plant
Assist with and perform validations and change controls for equipment, procedure, and process changes
Assist with and prepare risk management documentation in support of new and existing product lines
Responsibilities may occasionally require the individual to work on 2nd or 3rd shift and on weekends to support project or CAPA investigation needs
A minimum of 3-7 years of experience in the pharmaceutical or biotechnology industry in a Quality role
Understanding of statistics in support of fact based decision making
Communication (both written and verbal) skills, influencing and negotiating skills across all levels of management
Experienced user of TrackWise and Minitab preferred
Working knowledge of FDA Regulations and International Regulatory requirements
Understanding of risk management tools
Project management experience preferred
Available to work during off-shift or weekends on an infrequent basis
Candidate must not be allergic to Penicillin or Cephalosporin
BS/BA (4 years of university level education) in science, engineering or related field, or work experience in a related field with a minimum of 4 years of Quality Operations/Quality Assurance/Quality Control experience, or equivalent combination of education and experience
Greenbelt/ Blackbelt certification or equivalent experience using Six Sigma or other Lean Manufacturing tools preferred

Quality Associate / Engineer Resume Examples & Samples

Partner with engineering to correct non-conformances and/or recommend process changes to meet quality system objectives/requirements
Facilitate and manage non-conformance biweekly review board meetings
Assure product quality and customer satisfaction through the integration of quality systems
Assist with the enhancement of quality processes and systems
Assist in managing customer complaint and customer feedback processes
Assist in establishing, analyzing, and reporting quality trends for key quality indicators to assist company decision-making process
Support Project Management through project document development (specifications, verification plans/protocols, verification reports, etc.)
Conduct Internal and Supplier audits as assigned
Assist in monitoring Quality Management System including assisting with Audit finding resolutions and help manage suppliers
Assist in continuous improvement activities
Develop or assist in the development of standard operating procedures and work instructions
Provide training and coaching of personnel in all functions to understand and comply with customer quality requirements and model quality system requirements
Lead root cause investigations, corrective action determinations, and verification (CAPA) using proven quality tools and methodologies
Assist in management of document changes within Quality Management System
Bachelor’s Degree within Engineering or similar discipline
2 + years quality engineering experience
2 + years training and/or experience with root cause analysis and corrective/preventative action implementation
2 + years Knowledge and understanding of ISO 9001 Standards
2 + years’ Experience in conducting internal, external, and supplier audits

Quality Associate Resume Examples & Samples

Ability to respond to customers (Internal and External) in a timely manner
Ability to build relationships across functional boundaries at multiple levels internally and externally
Strong process mindset
Strong Microsoft Excel skills for metrics
Thorough knowledge of applicable procedures, specifications, regulations and standards. Understands regulations for Medical Device and component suppliers
Strong technical writing skills; able to clearly document audit findings within audit reports
Bachelors in science, engineering or technical discipline
Lead Auditor training, ISO Lead Assessor training, with 2-3 years experience in auditing techniques, interpreting regulations and quality systems
Minimum of 5-8 years of experience in Quality, or related field in the medical products industry
TrackWise experience preferred
Strong technical writing skills. Must be able to clearly document audit findings within audit reports
Strong technical, analytical and problem solving skills
Good interpersonal / communication / influencing / negotiation skills

Quality Associate Resume Examples & Samples

Continuous stakeholder communication across a variety of departments involved in the production processes of leading cloud applications
Ensure and document quality aspects of the delivery cloud software and its delivery processes
Support high business outcome by improving quality on a continuous basis
Continuously improve continuous delivery pipelines on a productive cloud infrastructure
Bachelor or master’s degree in Computer Science or Business Informatics
Excellent programming skills in at least one of the following languages: Java, Javascript, Scala
Strong expertise in high-quality code, software standards and its documentation
Proficient in agile development processes (e.g., SCRUM, Kanban, XP, TDD)
Good understanding of test automation methods and tools of the JVM ecosystem
Excellent English and German language skills - written and oral
We are looking for candidates with 0-3 years of experience. Please attach a list of projects you have been working on including your role, used technologies and applied development processes

Quality Associate for Variant Configuration on S Resume Examples & Samples

Implementation and execution of test scripts for the Fiori-based user interface based on specification
Preparing test data for manual and automated tests
Documentation of test results and following up issues
Good university degree in computer science or a related discipline
Basic knowledge of web technologies like JavaScript, HTML, CSS, Java
Basic knowledge regarding test methodologies
Flexibility and willingness to learn new subject matters quickly
Good analytical skills combined with the willingness to work on complex topics and drive its realization in an efficient way
Fluent or near-native German and English language skills
Basis knowledge of SAP technologies like Fiori, HANA, ABAP, and Netweaver
ISTQB certified tester – foundation level

Quality Associate Resume Examples & Samples

Lead and support on-site audits and review of 3rd party audit reports / corrective action responses. Ability to travel up to 35% including internationally
Utilizes the Global Supplier Quality Trackwise System (GSQTS) for maintaining Supplier Quality Records
Identifies Baxter supplier compliance issues; helps to resolve issues in a timely manner
Partners with facilities, divisions, and regions to ensure successful implementation and compliance to procedures / regulations
Own and resolve supplier related CAPA(s). Analyze supplier related defect data to determine root cause
Understands and assures conformance to regulations for Drug and Biologic suppliers
Participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk
Interacts frequently with subordinate supervisors and functional peer group managers
Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements
Experience within Drug/Biologic (API) manufacturing and quality operations
Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices (standards ISO9001, ISO13485, ICH Q7, 21 CFR Parts 11, 210, 211, and 820)
Good interpersonal/communication/influencing/negotiation skills
Bachelor’s Degree in Science or Engineering required
Minimum of 5+ years of experience in Quality and API manufacturing or related field in the medical products industry
Strong technical writing skills. Must be able to clearly and independently document audit findings within audit reports

Quality Associate Resume Examples & Samples

Ensures that customer complaints are received, documented, investigated, and reported in accordance with applicable procedures and regulations
Liaise with Global Drug Safety/Pharmacovigilance and manufacturing sites to conduct quality investigation of safety signals or Adverse Events
Responsible for the process of assembling and reviewing line listings and other complaint related data, this consists of routine listings as well as audit related requests
Communicates with internal and external customers for more complicated and involved customer issues
May work with Medical Directors in the assessment of complaints in relation to determining causality
Works with other GPS (product surveillance) personnel to determine the appropriate inspection/testing activities to be conducted
Responsible for the process of determining and documenting the rationale for the closure of complaints
Participates in CAPA investigation related to complaint issues. Will provide data, input, and support to the CAPA team
Possess superior organizational skills and be very detailed oriented
Knowledge and understanding of Global regulations pertaining to drug and device complaint management (eg. 21 CFR § 211.204, and §211.198, MEDDEV 2,12/1 etc.)
Knowledge of computer systems for word processing, data analysis and complaint management
Able to work effectively in a multi-functional team environment and across all levels of the organization
A functional understanding of FDA, ISO and Quality systems is required

Catalog Quality Associate, Spanish Resume Examples & Samples

Identify generic patterns in browse and audit to be translated into guidelines and SOPs to improve overall audit outcome
Must be flexible to meet business requirements & work with high priority/visibility English content for other marketplaces such as US, UK & IN
No extensive spoken/written communication in Spanish on a regular basis. Should be competent to independently communicate both written/spoken with stakeholders/clients, in case required
Graduation or Post Graduation in Spanish from any reputed university
Advanced Diploma in Spanish along with Graduation in any field
DELE B2 & above in Spanish fresher/with work experience
0 to 2 years of working experience in online retail operations or similar fields

Catalog Quality Associate, Italian Resume Examples & Samples

Ability to make logical decisions while performing audit tasks even when provided information is ambiguous
Review authoritative sources to validate catalog data when needed
Provide feedback to streamline existing processes to help the team achieve more consistent results with high quality
No extensive spoken/written communication in Italian on a regular basis. Should be competent to independently communicate both written/spoken with stakeholders/clients, in case required
Graduation or Post Graduation in Italian from any reputed university
Native Italian / Diploma in Italian along with Graduation in any field
Candidate must demonstrate language proficiency in all the following: verbal, writing, reading and comprehension
Familiarity with online retail (e-commerce) and Internet search industries
Adult content
Religious and philosophically sensitive issues

Quality Associate Resume Examples & Samples

Leading Supplier Qualification activities including audits and negotiations of Quality Agreements
Managing relationship with suppliers and issue resolution
Managing SNCs and quality approver function for SNCs
Independently manages complex issues, projects, programs, processes and relationships on behalf of MLCM
Representation of MLCM and making quality related decisions on behalf of the function
Support training, coaching of other experts and coordinates work of other team members
Lead multiple tasks/projects within timelines autonomously
Resolves complex problems, is accountable for problem identification, root cause analysis and managing resolutions
Responsible for the implementation of quality systems in MLCM departments and managing compliance
Responsible to assure conformance to regulations applicable to MLCM
Interface with suppliers, stake holders and regulators during inspections
Process ownership, and document owner and approver for quality and technical documents
Synthesizes knowledge of the business and professional standards to provide program advise to business leaders
Provides leadership for tactical and strategic for business needs
Expertise in cGxP regulations and compliance requirements
Respect for individuals and the diverse contribution of all
Thorough knowledge of applicable healthcare procedures, specifications, regulations and standards
Experience in pharmaceutical manufacturing and quality operations
Highly experienced professional, providing process and program design advice
Simplify the complex without losing the overview
Ability and willingness to adapt in course of changes
Fluent in English (verbal, written and oral)
Good knowledge of MS office
Proficient in multiple quality systems including supplier quality, statistical techniques, regulatory requirements, documentation control, Material Management/Material Qualification Processes etc
Proficient in complex problem solving through the use of quality tools
Thorough technical capabilities

R&D Quality Associate Resume Examples & Samples

Reports to the Senior Quality Associate GCP
Health Category covers Medicinal Products, Medical Devices, Cosmetics and General products
Covers clinical activities worldwide to support NPD and global roll-out of marketed products
Approximately +25 medicinal product studies and +50 other product studies are supported annually
Ensures compliance to RB quality policies and procedures and to international standards of GCP, applicable regulatory requirements and ISO 14155 and 13485
Ensures that the quality assurance system is established, implemented, maintained and monitored in accordance with relevant standards
Conducts audits to international standards of GCP, ISO 14155 and 13485
Reviews and approves the corrective and preventive actions (CAPA) arising from internal/external audits
Assists in the investigation and resolution of system deviations and clinical trial breaches
Completes risk assessments on vendor management activities
Assists in the assessment of GCP quality system documentation such as change controls and quality SOPs
Provides GCP training to R&D employees
Is actively involved in the preparation for and the management of inspections by regulatory authorities
Supports implementation and oversight of CAPA resulting from regulatory inspections and other issues that may impact quality
Monthly reporting of key quality performance indicators for management review
Updating, maintaining and improving the Quality manual with respect to GCP requirements
To prepare and present review of the company’s QMS to ensure it’ continued suitability, adequacy and effectiveness in conducting clinical trials
A degree or equivalent in a relevant scientific discipline
Excellent understanding of GCP and clinical trials regulation and compliance requirements
Results oriented, entrepreneurial and self-motivated, with solid planning and organisational capabilities, a bias for action, and the capability to define, evaluate and take risks
Lead Auditor Trained
Excellent communication skills and experience of influencing and leading cross functionally
Proven ability to work under pressure without compromising on deliverables
Capable of building strong working relationships to deliver outstanding results with or without hierarchical relationships
Experience within a large pharmaceutical company or CRO as a quality professional
Excellent understanding of GVP and safety reporting
Strong analytical skills with the ability to develop measurable implementation plans and able to transform solid thinking into action
Experience in defining and maintaining a quality management system supporting clinical trial processes
As well as supporting the internal quality management system supporting the clinical trials, the role is required to support external and internal focus activities as defined below

Quality Associate Resume Examples & Samples

Manages change control for Analytical documents
Reviews methods and specifications to ensure alignment with Good Manufacturing Practices (GMPs) and other applicable worldwide regulations
Review and approve production and analytical documentation accompanying the release of API, Safety Assessment or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements
Scientist communicates and resolves comments with client areas
B.S. and/or M.S. in an appropriate Science or Engineering discipline
1 year of experience required with a B.S
Experience should be in the pharmaceutical/chemical industry or government drug-regulatory agency with a working knowledge of cGMP regulations
Effective communications (oral/written) and interpersonal skills are necessary

Quality Associate Resume Examples & Samples

A bachelor’s degree in health science related field (e.g., pharmacy, nursing, chemistry, biology, or engineering)
Two years of regulated industry experience (e.g., exposure to cGMPs) with demonstrated knowledge of related quality systems
Strong Lilly product knowledge relating to how products work medicinally and functionally
Solid collaboration, teamwork and interpersonal skills
Strong verbal and written communication skills in English
Self management / motivated
Above average computer literacy and computer skills - specific training relating to software used will be provided
Strong curiosity skills with the ability to question/identify issues & work to resolution
Strong critical thinking/problem solving skills with an ability to apply rationale
Ability to mentor/train others - share learning
A health care professional background (e.g., degree in pharmacy or nursing)
Experience writing requirements documents (e.g., procedures) & developing training materials
Experience within the field of parenteral products, dry products, or devices

Multifunctional Quality Associate Manager Resume Examples & Samples

Must have at least 5 years of recent aircraft maintenance experience on F-16 aircraft
Must have at least 1 year of QA supervisory experience in an O-level maintenance environment, either within the aerospace industry and/or the military
Must have been previously awarded an USAF 7 to 9 level rating or the Marine/Navy Level IV MATMEP rating
Ability to evaluate process compliance, write/review Corrective Action/Preventative Action reports, perform root cause analysis, and validate quality processes, responses, and plans
Strong leadership skills and the ability to integrate a cooperative, resolution-focused quality function into the maintenance environment
Experience with aerospace ground equipment (AGE); Hazardous Waste Management programs; safety programs; maintenance information system; formal/on-the-job training methods; tool & FOD industry standards; equipment calibration procedures; general security procedures
Able to read/interpret engineering drawings/instructions; system schematics/blueprints; and technical policy/maintenance instructions
Experienced User of the Microsoft Office Suite software
Possess effective communication skills for coordinating with Aircraft Managers/Supervisors, Field Service Reps, System Engineers, Maintenance Logistics Support Managers, Customer and maintainers regarding quality issues, Instrumentation System Integration, Deficiency Analysis/Reporting, customer complaints, and other issues related to higher quality as they occur
Good organizational and administrative skills
Ability to speak or communicate in Arabic
Ability to work in a diverse work culture
Aircraft weight and balance experience

Principal Quality Associate Resume Examples & Samples

Comply with all job-related safety and other training requirements
Act as a technical resource for support of systems and new product introduction by proactively interpreting regulatory and compliance requirements, establishing and maintaining systems
BS/BA in a scientific or related field plus 5 years’ experience in the pharmaceutical industry
5+ years’ experience in Quality Validation. Prior experience in “computer system validation” is A MUST! This position will be reviewing all GMP computer system validation documentation (SAP, Document Management system, Trackwise, and other cGMP computer systems). Knowledge of validation processes required
IT/Technical background preferred

Junior Quality Associate Resume Examples & Samples

Responsible for the creation of test cases, test plans, as well as of for test execution. In addition you coordinate test campaigns as needed in accordance to the project’s milestones
Create defect reports/tickets and follow up until issues are successfully solved. Contribute to triage and prioritization of issues with your Scrum Master and Product Owner as needed
You keep your team on top of their software quality milestones and KPIs
You coordinate with other teams and colleagues (QA engineers, delivery managers etc) across locations in your program
Report regularly on your team’s testing and QA activities (Sprint Reviews, Q-Gates etc)
You enjoy a strong technical environment and are not afraid to get your hands dirty with test script automation tasks
You actively learn new technologies and business processes (ERP, Retail, Wholesale Distribution and Fashion Management)
You are a strong team player and go the extra-mile in support of your team
You are keenly aware of software engineering principles as pertaining to quality assurance
Strong foundation in computer science with solid understanding and competencies in: operating systems, data structures, algorithms and software design in general
Good English language proficiency (verbal and written)
Local candidates preferred
The ideal candidate would be able to start by January 2017
Knowledge of test automation tools and frameworks a strong plus
Knowledge of key web technologies: HTML5, JavaScript a plus
Agile development experience (Scrum, TDD, Continuous Integration) is an asset
Successful completion of an internship a plus

Senior Quality Associate Resume Examples & Samples

Signature competency as a part of routine job activities, Accountability for job activities
Follow up, review, facilitation and approval of deviations
Follow up, review, facilitation and approval of change control
Ensure timely Change Control implementation, deviation/investigation review and CAPA closures at the CMO
Work with CMO partners to ensure they meet Shire Supplier Quality requirements
Identify and escalate Quality and Compliance related issues between CMO and Shire to QALead
Participation to quality risk assessments; develop mitigation actions and follow-up on CAPA implementation and lead quality/process improvement initiatives at the CMO
Monitor quality performance metrics
Work with Shire employees across multiple global sites and functions to assess the impact of CMO changes and/or risks
Develop, execute and support the Quality System integration plan for new acquisitions
Assuring compliance of the on-site Quality Team to External Plasma Quality procedures
At least 5 to 7 years of Experiences in Pharmaceutical Production, preferentially in plasma products
An experience with CMO (Contract Manufacturing Organization) would be an asset
Strong experience and skills in GMP, Quality Management and organizational topics
Very good Communication Skills
Critical Thinking & Problem Solving
Dealing with Ambiguity

Senior Quality Associate Resume Examples & Samples

Ensuring that all manufacturing and quality processes and procedures at Catalent are performed in compliance with local and Corporate GMP and quality requirements
Assisting the Quality Manager with the Company’s quality programs to ensure that TGA, Corporate and Catalent quality and GMP requirements are met
Providing technical advice to Production areas on GMP and Quality related issues
Some shift work may be required
Ensuring that all products released for supply at the Dee Why site are reviewed for compliance with regulatory requirements and with the market authorization
Adhering to core company policies and procedures including Quality, GMP, EHS/OHS, Ethics, EEO etc
Significant experience in the pharmaceutical industry, preferably in QA / Compliance and have a sound understanding of GMP Principles
Excellent understanding of the Code of Good Manufacturing Practice (GMP) with the ability to apply to the code to a variety of processes
A sound understanding of the Code of Good Manufacturing Practice
A sound knowledge of computer skills, e.g., Microsoft Word, Excel and power point
A demonstrated ability to developed, maintain and/or administration of a Quality Management. Systems, and in particular documentation systems (e.g. SOPs, Work Instructions, Forms etc.)
Experience in investigating customer complaints and deviations ensuring they are closed out in accordance with approved procedures and timelines
An ability to work well under pressure and prioritize tasks
Participate in, and conduct audits and training as required
Be able to communicate effectively to a wide variety of stakeholders including Quality, Operations, Contractors, senior management and external customers
Ian ability to identify, implementing continuous improvement initiatives and processes
Developing others to broaden and strengthen their skill base and opportunities within the Team

Quality Associate Resume Examples & Samples

High school diploma or general education degree (GED); one to three years related factory quality experience and/or training
Comprehensive knowledge of PC’s, scales, refractometer, ovens and other office equipment
Comprehensive knowledge of manufacturing environment
Comprehensive knowledge of the Code of Federal Regulations that deal specifically with food, meat and poultry
Comprehensive knowledge of the OSHA requirements for the job assigned

Quality Associate Resume Examples & Samples

Close cooperation with Development and Product Management to understand risk areas and organize your test efforts accordingly
Test effort estimations and creation of test cases
Manual Testing, Documentation of results, status tracking and feedback to development
Analysis of server logs, Analysis of Customer Issues, solution proposals to development
You have a bachelor or master degree from academy of cooperative education in the following fields: business, information technology, computer science, mathematics, applied sciences, engineering or related area
Required skills
Very good analytical skills
Strong quality focus
Good technical skills
Familiar with testing techniques (e.g. black box and functional testing)
Ability to quickly understand customer business requirements
Strong social skills and team player – consensus building and self confidence
Strong English and German language skills
Preferred skills
Experience of application development especially in the HCM area is an advantage
Experience with local development environment (Eclipse, SVN, …)
Knowledge of Java, JavaScript, Objective C is an advantage
We are looking for candidates who are passionate about quality and committed to a career path in business software development

Senior Quality Associate Resume Examples & Samples

For processes and projects of moderate complexity, perform compliance assessments, make decisions regarding regulatory requirements, write new procedures and ensure adherence to current regulations
Ensure quality of methods, processes, materials and products by providing coordination and review of group operations, staff training, and the assessment/improvement of systems and processes
Conduct risk assessments and take appropriate actions during quality system management and oversight activities (e.g. during review/approval) to ensure adequate controls in relation to the level of product quality, safety and business risks
Perform QA batch disposition (release) decisions
BS/BA in a scientific or related field plus 4 years’ experience in the pharmaceutical industry

Quality Associate Resume Examples & Samples

Comply with all job-related safety and other training requirements. It is the responsibility of each employee to work in a safe and responsible manner in order to create an injury-free and incident-free workplace
BS/BA in a scientific or related field
1-2 years’ experience in a Pharma manufacturing company working in an aseptic environment in a Quality capacity

Senior Quality Associate Resume Examples & Samples

Bachelor Degree in Science/ Life Science, Pharmaceutical Science or Engineering or proven relevant experience
Audit experience preferred. Good knowledge of Singapore, US and European regulatory requirement
4 – 6 years of relevant experience in quality assurance in pharmaceutical manufacturing environment, supplying to highly regulated markets such as FDA and EMA
Continues improvement mindset
Basic knowledge of scientific and technical concepts. Understands quality processes and has basic knowledge of statistical tools to support data evaluation. Basic knowledge of drug development process and associated quality processes
Good knowledge and application of Lean
To be familiar with simple statistic to apply statistical analysis and process control techniques
Experience in MS-office applications
Demonstrates active skill in challenging the status quo, offering practical alternatives
Possess ability to actively seek opportunities for improving department processes and increasing efficiency
Demonstrates capability in the application of appropriate troubleshooting, root cause analysis and problem solving techniques
Project management skill is preferred for the roll out of corporate automation system
Good knowledge of system lifecycle management

Quality Associate Resume Examples & Samples

Process requests for creation, revision, and obsolescence of controlled documentation
Edit and Review documentation formatting to ensure compliance with template requirements
Review documentation to ensure compliance with requirements for approval and implementation
Provide system clean-up within a biannual schedule
Review paper documents and file
Coordinate offsite storage for Quality Assurance
Create logbooks
Assist in quality system maintenance
Contributes to department goals and objectives
Proactively troubleshoot and identify solutions
Proficient use of Microsoft Word and Excel
Experience in document management within a regulated environment
Ability to work in a team environment as well as an individual contributor across a wide variety of individuals and projects

Catalog Quality Associate, Spanish Resume Examples & Samples

Good analytical skills and attention to detail
Upper-intermediate (B2) or Advanced level (C1) of English and Spanish with focus on reading and comprehension
3rd level (university) qualification preferred
Working experience in office environment
Knowledge of MS Word, Excel and Outlook

Catalog Quality Associate, Italian Resume Examples & Samples

Follow pre-defined processes, guidelines, and SOPs to perform audit tasks with high levels of accuracy and productivity
Should be competent to independently communicate in Italian with stakeholders/clients, in case required
Advanced Diploma in Italian along with Graduation in any field
Willingness to work with sensitive issues (Adult content; Religious and philosophically sensitive issues; Alcohol, tobacco, weapons and other potentially offensive products)

Quality Associate Resume Examples & Samples

Supports Critical Systems, Facilities Engineering and Warehousing for both LA and Van Nuys in various QA capacities
Supports top quality issues and improvement initiatives for both LA and Van Nuys
Represent QA support for Critical Systems, Facilities Engineering and Warehouse during regulatory and customer audits
Understands and deploy the quality systems that ensure products conform to defined requirements
Understands and ensures compliance to all applicable Shire policies and procedures as well as state, federal and international regulations
Coordinate the efforts between the Quality Assurance and Critical Systems & Facilities, Warehouse, Manufacturing departments to ensure compliance and timely resolution of exceptions
Interacts frequently with peers and senior management in ensuring the success of the business
Lead ongoing daily departmental activities for areas of direct responsibility and when required assist other Quality areas in the successful performance of these activities
Lead in-plant audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Shire quality requirements
Manages Interactions with regulators and customers concerning the quality of products, systems and processes
Support the project initiatives within the LA facility
Support the development and maintenance of the department budget
Thorough knowledge of quality system processes
Strong leadership skills and demonstrated success in managing a team
Success working with multifunctional, global teams
Good interpersonal, influencing, and negotiation skills required
Knowledge of Plasma Fractionation business helpful
Bachelor’s degree in Science or Engineering; advanced degree in the life sciences, physical sciences or engineering preferred
5+ years in Quality, Manufacturing, Engineering or related field in the biotech/pharma industry
1-2 years of supervisory experience preferred

Quality Associate Resume Examples & Samples

Perform daily donor record file review
Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual
Perform a review of donor center records
Perform weekly review of equipment incident logs
Verification and release of sample shipment
Perform Staging of plasma for shipment
Inspection and release of incoming supplies
Perform Weekly employee observations
Participate in the Quality Assurance meetings and be part of the Quality Assurance team
Assist the Center Quality Manager to ensure that cGMP regulations are followed
Assist the Center Quality Manager to ensure that SOPs are followed and regulatory requirements are met
Performs a review of the documentation of unsuitable test results and the disposition of the associated units
On an occasional basis, when the Center Quality Manager is absent, the Quality Associate may be required to perform the following duties
High School diploma or GED. Obtains required state licensures or certifications where applicable
Typically requires no previous related experience
Developing command of interpersonal communication, organizational and problem-solving skills. Ability to understand FDA regulations. Strong integrity and commitment to quality and compliance. Good knowledge of mathematics. Legible handwriting. Proficiency with computers. Ability to work flexible scheduling to meet business needs. Performs basic document review and employee observations. Communicates openly with the CQM on issues noted during reviews. Ability to understand and follow SOP’s and protocols. Ability to perform primary responsibilities of the Quality Associate role in a proficient manner. Has a basic understanding of cGMP and quality systems. Is able to spend hours sitting and reviewing documentation for accuracy. Demonstrates good organizational skills and attention to detail
Is certified and maintains certification in the donor processing area

Quality Associate Resume Examples & Samples

Usually works in a cross functional development or testing team with special focus to quality assurance and test related tasks within the product creation process
Analyzes, defines, implements and executes quality and test related activities according to a given quality and test strategy for the product area
Creates a detailed test design incl. test system landscape requirements and product standards, prepares tests (customizing & master data), authors and executes manual and/or automated tests
Analyzes test results (issues) and takes appropriate follow-up actions
Has basic product domain knowledge incl. relevant business processes & scenarios and a basic understanding of customer needs
Has proficient knowledge about relevant product and process standards, important legal requirements as well as quality assurance and test related tools
Has basic knowledge and technical competencies of relevant programming languages and related development tools and processes
Strong background of SAP Quality processes, Testing, Automation
High level of commitment towards ownership of product/topic will be the key for success
Plan and execute dedicated quality measures in the implementation team. Help the implementation team in test methodologies
Fully understand the specification and backlog items and make sure that you author high quality test cases
Analytical Quality Assurance (Test Coordination & Execution, Test Management Systems, Test Design Techniques, Test Automation Techniques, Product Standard Tests)
Standard Compliance
Preferred experience is 2+ years

Quality Associate Documentation Center Resume Examples & Samples

Coordinates and schedules testing of all product for the on-going stability and on-going sterility monitoring programs with the appropriate laboratories
Other duties and responsibilities as assigned
Demonstrated understanding of quality assurance in a regulated environment
Effective problem solving, strong communication (written and verbal) and organizational skills

Temporary Labeling Quality Associate Resume Examples & Samples

Support local quality management team to assure that production operation is maintained in a GMP compliant manner
Accurately count and inventory labels as directed
Produce labels for production operation as directed by manager
Inspect in process and final products as directed by manager. Report inspection failures to manager
Comfort with standard computer software and email
Prefer previous experience in a manufacturing environment

Quality Associate Resume Examples & Samples

Interpret regulatory requirements and provide guidance for effective compliance, as well as providing coordination / support for programs and projects
Provide oversight and management of various Quality Processes such as; Internal Audit Program, Corrective and Preventive Actions System, Change Control, Supplier / Co-packer Quality Management, Non-Conforming Material, etc
Improve existing and develop new Quality Processes, writing and implementing associated procedures and other documentation
Conduct investigations of undesirable trends in production processes performance and unplanned events, perform root cause analysis, and develop and implement corrective and preventive actions
Conduct audits of suppliers and contract manufacturing firms in order to determine the effectiveness of their quality systems, as well as their capability to provide compliant goods and services. (May require frequent travel, including international.)
Provide technical guidance and facilitate problem-solving methodologies regarding quality-related issues
Provide training and guidance to ensure compliance with Regulatory Requirements and Guidance, Standard Operating Procedures (SOPs), Departmental Operating Instructions, protocols and other governing documentation by Operations and Quality personnel

Quality Associate Resume Examples & Samples

Work with Quality Supervisor to maintain organization of the Quality Assurance document systems
Utilize Microsoft Excel and Access to support data systems and analyze data collected through systems to support plant and division initiatives
Manage and maintain Supplier Performance Evaluations (WISPER) for the plant to ensure alignment with division and corporate standards
Perform basic quality inspections of finished goods or work in progress to support plant processes and initiatives
Assist in training of new employees on Eaton Shawnee Quality processes and policies
Develop understanding of Shawnee quality systems to support Eaton Quality Systems initiatives
No relocation benefit is being offered for this position. Only candidates that currently reside within the immediate geographical area of Shawnee, OK will be considered
This position requires use of information or access to hardware which is subject to the International Traffic in Arms Regulations (ITAR). All applicants must be U.S. persons within the meaning of ITAR. ITAR defines a U.S. person as a U.S. Citizen, U.S. Permanent Resident (i.e. ‘Green Card Holder’), Political Asylee, or Refugee
Associate’s Degree and/or additional certifications in Microsoft Office (specifically Excel or Access)
Minimum of 1 year previous experience as a Quality Associate or Quality Clerk
Minimum of 1 year experience utilizing Microsoft Excel to develop, maintain, and analyze data
Demonstrate excellent written and verbal English communications, problem solving, and customer relations skills
Advanced understanding of Microsoft Excel to develop and maintain data analysis systems
Advanced understand of Microsoft Access to develop and maintain data analysis system
Strong organizational skills with ability to manage and track multiple projects to completion
Ability to read, understand, interpret, and effectively apply information contained in all applicable documents such as operating instructions, engineering drawings, specifications, design standards, dimensional sheets, and/or blueprints (including geometric dimensioning and tolerancing)
Ability to function effectively with minimal supervision in a high involvement, team oriented work atmosphere, coordinating work with area supervisors, engineers, quality control, technicians, peers, and customers
Willingness and ability to occasionally travel to customer locations
Demonstrate basic computer data entry skills and ability to properly utilize Oracle and Microsoft Office software
Prior history of satisfactory operation of mechanized material handling devices such as fork truck and scissor lift and/or willingness and ability to complete and pass training/licensing course within first week in this classification
Ability and willingness to work overtime, weekends and any shift as needed

Quality Associate Resume Examples & Samples

Manage activities of self to achieve defined quality goals in an efficient, accurate, and timely manner
Ensure team is performing required tasks associated with company procedures, government regulations, and guidelines to maintain compliance. Prioritize and schedule work assignments, as required to meet department goals
Interface with quality, manufacturing, and technical support groups to resolve issues related to Quality Systems. Provide innovative solutions and drive continuous improvement initiatives in the areas of Change Control, CAPA and Complaints for compliance to internal/external quality and customer requirements
Review and ensure system requirements and documentation is complete (e.g. checklists, logs, binders, etc.), accurate, and in compliance with internal/external quality and customer requirements
Perform Product impact assessments for Events/CAPAs/Complaints/Post Donation Information to determine if additional action is needed (e.g. BPDN, potential FCA assessment, etc.) and facilitate timely release of Product Holds
Provide oversight and/or directly manage and/or approve change controls and nonconformances (e.g. Events, CAPAs, etc.) per applicable procedures. Mentor Change Owners, Task Owners, Quality Approvers, Event, CAPA, and Action Owners
Provide Change Control/CAPA/Complaint business process and systems training. Grant system access to trained individuals. Lead in the development of customer training, awareness, and understanding of activities for areas of direct responsibility throughout the facility
Lead and/or actively participate in Change Control and CAPA operating mechanisms at defined frequencies (e.g. Change Control Board, (CCB), Event Review Board (ERB), CAPA Review Board (CRB), CAPA Representative Meetings, etc.)
Ensure proper maintenance and data integrity of the various databases, which relate to quality operations. Responsible for change control activities and documentation for those systems (e.g. TrackWise 7 and 8)
Obtain feedback and input from quality and manufacturing functions to define enhancement requests for systems utilized to manage Change Controls and Events/CAPAs (e.g. TrackWise 8). Assist and/or write user acceptance test cases/validations for computer systems. Execute validations, as needed
Responsible for compiling and/or reviewing various key quality indicator trend/metric data at defined frequencies. Presentation of trend and metric data via Management Review mechanisms
Monitor Change Control and Event/CAPA systems to ensure timely, appropriate, and thorough resolution of nonconformance issues and closure of records. Identify and recommend when escalation is needed
Perform process audits to ensure departmental procedures are consistent with business and regulatory requirements. Approve department owned procedures through documentation change control, as needed to meet internal/external quality requirements
Lead and/or assist with audit ready status efforts of assigned areas. Assist other areas within the facility in understanding quality requirements. Maintain a high level of expertise in internal/external quality requirements, and serve as a facility resource for compliance to requirements
Ensure self 100% trained and qualified to perform essential duties. Provide coaching, guidance, and development to staff and less experienced individuals within the facility
Provide guidance and assist users with TrackWise system workflow management. Create queries, Ad Hoc reports, and data export templates for user and management visibility of Quality Systems records
Complete other tasks as assigned by management
Strong knowledge of Microsoft Applications (Word, Excel, Access, and Visio)
Must be detail oriented and have strong organizational skills
Ability to prioritize workflow and handle multiple activities and meet deadlines
Must complete tasks by following guidelines, procedures and policies
Thorough knowledge of applicable procedures, specifications, regulations and standards, as they apply to Quality Systems
Advanced knowledge of global computerized systems workflows, query functions, and reporting tools (e.g. TrackWise and Team Center)
Demonstrate strong problem solving skills for systemic root cause analysis through knowledge and use of statistical tools (e.g. Cause/Effect Diagram, Contradiction Matrix, Pareto Chart, etc.)
Must be self-directed and motivated to complete repetitive tasks
Must be sensitive to confidential information
Demonstrate excellent communication skills (written and verbal) and presentation skills
Ability to diplomatically interact well with coworkers
Demonstrate professional and diplomatic interactions with co-workers, cross-functional team members, and internal/external customers
Must be a team player and customer service oriented
Six Sigma or Lean Green Belt trained/certified or ability to be trained/certified in 12 months or less
Lean and/or Six Sigma Greenbelt Trained
Lead Investigator Training/Certification or equivalent (e.g. TrackWise 8 Investigation Owner)
Bioscience Certified Trainer
CAPA Project Ownership Preferred
Change Control Ownership Preferred

Quality Associate Resume Examples & Samples

Drive investigations and action plans (CAPAs) with regards to failures in the DC
Drive process improvement actions related to her/his activities
Perform dispositions related to quarantined and rejected items as per J&J Franchise instructions
Provide support to operations on the shop floor with relation to process improvement and error reduction
Perform internal and supplier audits
Perform Batch Release of products that are Repacked&Relabeled in the J&J Courcelles Distribution Center
Support Supplier Quality related activities, e.g. Supplier qualification and monitoring
Minimum Bachelor degree
2 to 3 years of experience in QA or other relevant experience
Strong Experience in a Warehouse environment is a plus. Supply Chain Knowledge is a must
Ability to connect with different stakeholders and identify right priorities for the team
Analytical and process minded
Solution driven
You are rigorous and can work independently
Good planning & organisational skills
System skills in Excel, Powerpoint, Word. Experience with ERP order management system (preferably JDE 8.12)
Knowledge of TRACKWISE system is an asset
Proven track on Credo
Language skills: English (good level in speaking and writing) – French (full professional proficiency) – other languages are an asset

Senior Quality Associate Resume Examples & Samples

Associates degree REQUIRED, BS/BA in a scientific or related field PREFERRED
Plus 3-5 years’ experience in Pharmaceutical manufacturing; production knowledge required
Familiarity with Steriles manufacturing
Good writing/documentation skills required!

Quality Associate Resume Examples & Samples

Lead ongoing daily CAPA Quality System activities for areas of direct responsibility and when required assist other Quality areas in the successful performance of these activities
Manage activities of self in achieving defined quality goals in an efficient, accurate and timely manner
Ensure business needs and timeliness requirements of the CAPA Quality System are met or exceeded globally
Recognized by various levels of sites as a CAPA subject matter expert and be able to demonstrate leadership ability
Understands and assures conformance to regulations in a section or department. Interfaces with regulators during regulatory inspections
Strong interpersonal skills and great attention to detail are necessary
Must be a strong team player with good problem solving, and good verbal and written communication skills
Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
BS in business/science or equivalent
CAPA Quality System training, Root Cause Analysis training, with 1-2 years of experience in owning and executing CAPA Quality System records
3-5 years exp. in Quality with a medical device/pharma company or other similarly regulated industry

Quality Associate Resume Examples & Samples

Write, review, analyze and revise written Procedures and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc
Lead in the development of customer awareness and understanding activities for areas of direct responsibility, and where appropriate, assist and support such activities throughout the facility
Provide guidance and coaching for the areas of responsibility as defined in items # 1 through #8 for less experienced individuals within the organization
Must have the ability to perform the responsibilities of the Quality Manager on an as needed basis
Understand scientific strategies and be able to invent new methods or new avenues of investigation
Good interpersonal/communication/influencing/negation skills
Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
Bachelor's degree in science or engineering; advanced degree in the life sciences, physical sciences or engineering is ideal
CAPA Quality System training, Root Cause Analysis training, with 2-3 years of experience in owning and executing CAPA Quality System records, interpreting regulations and quality systems

Senior Quality Associate Resume Examples & Samples

Develop adequate understanding into regulatory guideline, company policies, procedure and standards
To ensure site is in compliance to regulatory guideline, company policies and standards, conduct walk through audits, internal audits in all GMP relevant systems as per schedule. Present audit findings to all levels of management
Applies knowledge of internal and external compliance requirements (e.g. EU GMP, US FDA) and quality guidelines to all aspects of product specifications, manufacturing processes, warehouse/ distributions systems and lab functions
Coordinate Quality Risk Management on site, including site risk register administration
Prepare, co-ordinate, conduct walkthrough, internal and/or supplier audits. May function as a lead auditor which assumes the responsibility of coordinating the efforts of a team of auditors and leading the audit process
Participate and coordinate regulatory agency inspections and corporate audits. Assist to follow up all action plans and ensure effective regulatory commitment tracking to assure no overdue CAPA
Work closely with other functional groups to raise the level of awareness towards cGMP, company policies and procedure, regulatory guides and codes
Co-ordinate and support regulatory submissions made by site
Maintain Quality Compliance Department files, performance metrics and other general administrative tasks
Manage site quality council meeting preparation and collate site quality metrics for reporting to site and corporate management
Participate in continuous improvement initiative as part of the MPS culture in MSD Singapore
Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable
Supervise and oversee Third Party Contractors, where applicable
Perform any other tasks as assigned by manager
Able to interpret and apply Quality System to ensure adherence to quality standards/ guidelines and achieve a state of control
Frame the correct problem statement when conducting audit, partner with various functions providing guidance in root cause analysis and problem solving techniques
Liaise with Regulatory Affairs for site regulatory submissions, ensuring data accuracy
Manage and perform audits using thorough understanding of audit management methodology
Able to develop audit reports with minimal oversight. Communicate audit plans, findings and overall audit outcomes to internal and external groups. Able to assess CAPA effectiveness, trends and potential quality impact to drug products
Able to independently solve problems that arise within job responsibilities and expectation. Able to organize information in a logical way and combine data and information from multiple sources in new ways to determine causes of issues
Bachelor Degree in Science/ Life Science, Pharmacy, Pharmaceutical Science or Engineering or proven relevant experience
Auditing experience is required
A continued improvement mindset

EM Quality Associate Specialist Resume Examples & Samples

Execute assignments that focus on deviation management, sample collection, continuous improvement, environmental control, standardization of business processes and compliance
Collaborate with members from other support groups within the organizations, such as Operations, Technology, and Quality, in the identification and implementation of continuous improvement initiatives and action plans
Author environmental monitoring documents, protocols, reports and/or investigative studies
Perform data analysis of environmental monitoring data
Participate in Go-Sees in collaborations with Operations, Technology, and/or IPT Quality
Evidence of leadership skills coupled with good oral and written communication skills
Evidence of problem-solving and data analysis skills
Work experience in a laboratory, technology, manufacturing, or quality position
Knowledge of aseptic processing operations, vaccine and/or pharmaceutical processing
Understanding of cGMPs as they apply to the pharmaceutical industry and/or a related industries
Experience in environmental monitoring or environmental control

Senior Quality Associate Resume Examples & Samples

3-5 years’ experience in Pharmaceuticals (Steriles or biotech manufacturing environment)
Previous experience in Steriles production STRONGLY PREFERRED
Ability to troubleshoot process and equipment issues
Self-driven, demonstrated ownership & responsibility; Ability to lead, support & motivate a Team
Technical Writing experience
Professional certifications (ex: CQA) and training (Six Sigma) is a PLUS

Quality Associate Resume Examples & Samples

Proficient in Microsoft Word and Excel, computer software
Sound industry knowledge, project proficiency, and autonomy expected. May be considered a Subject Matter Expert (SME) in various disciplines
Must be able to identify opportunities for optimization of processes within the department or the plant
Ability to work independently or in teams
Ability to work any shift (1st, 2nd or 3rd) and any day of the week (7 days) as duties require
3 - 5 years related experience in Quality with a medical device/Pharma company or similarly regulated industry

Intern Global Quality Associate Resume Examples & Samples

Proficiency in Microsoft Office Applications (Excel, Powerpoint, Word)
Knowledge of web application development (HTML, JavaScript)
Basic knowledge of Google Apps
Basic knowledge of general business processes (ex: financial accounting)
Critical thinking on how to leverage existing resources and technology to bring value to the business
Strong analytical skills to present data in a innovative way to business leaders
Ability to manage complex situations and make decisions in a timely manner
Time management and ability to prioritize and re-assess schedules and tasks quickly and effectively

Quality Associate Resume Examples & Samples

Function as Quality Core Team member supporting new and improved (LCM) product design and implementation projects (including potential large programs)
Responsible for defining scope of quality deliverables and support for project team
Review and approve D&D documents including protocol and reports for quality and scientific content (business language is English). Obtain agreement with the author of the documents in case of missing requirements. Requesting additional concurring personnel if necessary
Participate in management and ensure follow-up of inspections including external inspections
Provide Guidance on maintenance product Design History Files and Risk Management Files according to relevant Quality System and other regulatory requirements for therapeutics and medical devices
Computer skill
Language skills
3 to 5 years experience in the pharmaceutical/medical device environment

Quality Associate Resume Examples & Samples

Perform efficient and accurate product testing(raw material, in process, finish product,) as per plan and in line with customer specs/standards, in coordination with dispatch/planning ,prod department
Perform electrical, geometrical, FRLS , fire testings, mechanical testing
Perform hot set testing on line
Maintain product test data and its analysis
Test report generation, releasing the product production,for dispatch, raw material for production
Ensure Skillful and safe and proper handling of instruments in lab. Maintain Lab housekeeping and Safety
Maintain lab equipment, tools and spare parts
Clearance of material in SAP according to test results
Analysis of customer rejected martial. Face external inspection,help preparing documentation
Hold the material for quality reasons and quarantine the NC material and ensure disposal
Escalate Quality problems in the raise NC note
Monitor non conformities of raw material ,Finish product
Maintain product test data,its analysis and monitor the Quality performance
Maintain and control the specifications/ standards
Focus on Result
Team Management
Analytical Problem Solving and a solution seeking mindset
Inter disciplinary thought

Quality Associate S Resume Examples & Samples

Define the operational test plans – systems, clients, test scope, test approach
Execute activation tests (Installation tests for Best-Practice configuration) for new installations of customer landscapes, upgrades from the last release or updates of Hotfix collections
Execute E2E implementation tests simulating customer implementation projects in the internal landscape – activities range from activation of new country solutions, performing configuration settings, define customer specific organizational structures, to consistency checks of configuration
Provide reporting to central program management and Senior management team
Bachelor’s degree in computer science, business administration or related field
First experience in quality engineering or in a SaaS Cloud DevOps role in a software company
First experience working in an international, multi-cultural setup
Excellent communication skills in English, ability to interact with team members, project leads and developers in a global work environment
1-2 years in a technical Quality engineering or DevOps role
0 – 10 %

Boss Quality Associate Resume Examples & Samples

Review transactions for accuracy and completeness and return inaccurate or incomplete transactions to the Processing Associates for correction
Review work items that have been completed by department Quality Assurance Associates
Contribute to the maintenance of department procedures
Maintain with consistency department quality and productivity expectations
Demonstrate resourcefulness and initiate creative ideas to reduce errors and improve quality

Quality Associate Resume Examples & Samples

Ensure that any unusual or unexpected observations that relate to product are investigated to determine root cause, and are appropriately resolved including ensuring that the appropriate CAPA documentation is initiated when appropriate
Scientific University degree (Engineering, chemistry, biochemistry...)
Knowledge of FDA (21 CFR Part 210 & 211), ICH, and EMEA regulations (EU GMP Part I & II) and ISO 13485 and 14971
Experience in leading project teams and Quality Initiatives (processes, systems, improvements) in an international environment

Quality Associate Resume Examples & Samples

Define the operational test plan – systems, clients, test scope, test approach, test cases
Follow up on test results, address and resolve blockers and work towards a high quality delivery to meet defined KPIs
Analyze and follow up on the results of static checks
Support developers in the maintenance and support of delivered Cloud releases
Work on ongoing improvements in test strategy, test approach and tools
Bachelor/Master degree in computer science, natural sciences or related fields
First experience in quality engineering, as consultant in SAP implementation projects or in a SaaS Cloud DevOps role in a software company
Experience working in an international, multi-cultural setup
Excellent communication skills in English and German, ability to interact with team members, project leads and developers in a global work environment
Strong willingness and ability to learn

Senior Quality Associate Resume Examples & Samples

Serving as a liaison between the call evaluation vendors and Travel Operations by facilitating calibration between Travel Operations leaders and vendors for Trust and Quality Monitoring assessments to ensure call review accuracy. Further, the role reviews disputes and delivers information and feedback to the vendor for further assessment and communicates the outcomes to the Travel Ops leaders
Creating weekly and monthly Agent performance (Quality Monitoring and Trust metrics) reports leveraged by all levels of Travel Operations leadership for trending and coaching purposes. Moving forward this person will aid in building more dynamic reports for ease of access and use
Identifying Agents that are not being recorded in NICE to ensure that each agent receives the appropriate number of evaluations
Create and maintain numerous reports currently in Excel using more of the advanced Excel functionality. Various reports are critical as they provide the Travel Operation leaders information needed for coaching purposes and to make decisions. Reports are also provided to the vendors to ensure Agents are evaluated
Create more dynamic reports for our clients, using more advanced tools, either in Business Objects or other systems
Communicate with call evaluation vendors delivering information, providing feedback, and answering questions
Listen to calls and review disputes (Trust metric) and providing findings to the Travel Operations leaders and vendors
Identify Agents not being recorded to ensure calls are valid for evaluation purposes
Complete requests and reports as needed based on requirements from the business used to make critical decisions
Proven work experience with Excel such as creating formulas to summarize data and a very proficient understanding of complex Excel functions
Demonstrated ability to understand and follow complex Excel formulas in existing spreadsheets
Using and creating reports in Business Objects
Good understanding of statistical functions
Proven problem solving and technical skills
Strong work ethic and ability to learn quickly
DRC Cast Members: No more than one F/O (F=Falling Behind and O=Off Track) in Presenteeism in the last six months and no more than one reprimand with in the last six months
Experience using SharePoint
Experience using the NICE recording system
Experience with Disney Reservation Center (DRC) systems such as Travel Box, Dreams, A La Carte
Demonstrated knowledge and understanding of the Walt Disney World Resort culture and operations
Associate Degree

Quality Associate Resume Examples & Samples

QA of manufacturing operations (Production)
Effectiveness
Validation
Metrics/Statistics
Equipment & Facilities records
Good Documentation Practices (GDP)
Document & Records Services
Compliance, Internal Audit
QA – Postmarket Surveillance
Complaint Handling
CAPA/NCR
Calibrations and Preventive Maintenance
Ability to organize and prioritize work load to meet deadlines
Ability to work as a team member, attention to detail

Quality Associate Intern Resume Examples & Samples

Work in an international team and support customers world-wide by solving their product issues, creating support corrections and providing documentation
Execute manual and automatic test cases and report product defects to the responsible team
Available as contact person for most questions regarding quality, process and compliance issues
Support internal teams who need quality management specific advice and knowledge
Contribute on continuous improvement of software quality (stability, robustness, performance, TCO, ...)
Provide support and training to other colleagues
Participate to important projects
Provide regular product feedbacks or customer feedbacks
Work experience in software development or maintenance
Work experience in software testing execution (automation, manual, etc.)
Work experience in setting up test framework or building test scripts
B.S or above in computer science, software engineering or mathematics, etc
Knowledge about SAP software development processes including product Standards (PIL) and validation and assembly processes
Knowledge about SAP’s product, quality and process standards
Good analytical, problem-solving skills
Strong listening and time management skills
A tenacity and patience to seek pragmatic and effective solutions
Good oral and written communication and presentation skills in English

Quality Associate Resume Examples & Samples

Conduct quality process audits
Ensure compliance to standard work instructions and address non-compliance issues
Create, review and modify standard work instructions
Perform product inspections using AQL
Will participate in cross-functional teams to identify effective corrective and preventive actions to improve process / product quality
1 year experience in Quality, Operations, or related field in the mobility management environment
Medium PC skills including Word and Excel
Demonstrated understanding of quality techniques as audits and inspections

Operational Quality Associate Resume Examples & Samples

Support operations on quality related issues
Managing SMEs for deviation and batch release processes
Oversee final product release to meet shipment plan and release cycle times
Oversee deviation, OOS and supplier deviation review and approval processes
Perform daily GEMBA to identify and rectify quality issues
Identify quality improvement opportunities related to operation’s current processes
Be the quality representative for the introduction of new products and artwork initiatives
Approve and maintain Master Bills of Materials, Pharmacode Masters and Product Guides
Revise and approve manufacturing, packaging directions, rework directions and inspection protocols as required
Review and approve packaging artwork
Perform level 2 audits as either a lead auditor, member of the audit team or technical expert
Prepare audit plan with the audit team

Junior Quality Associate Resume Examples & Samples

Review documentation for accuracy and compliance to procedures and release or reject as appropriate (essentially analytical methods development/validation/transfer, stability methodsstudies, Reference Standard characterization)
Degree in Engineering or in Sciences (Pharmacy, Chemistry, Biochemistry…)
Industrial Pharmacist is an asset
Number of years of experience: 0 to 2 years in Pharmaceutical/medical devices industry per EU and/ or FDA requirements (GLP/GMP/ISO13485 regulation)
Experience in Quality Initiatives (processes, systems, improvements) is a must
Field of expertise: Analytical method development/validation, laboratory activities or stability studies is an asset
Lead Auditor training, ISO Lead Assessor training, with 2-3 years experience in auditing techniques, interpreting regulations and quality systems, GLP/GMP/ISO13485 regulation is an asset

Catalog Quality Associate, Chinese Resume Examples & Samples

Report audit results and communicate them to others within the organization
Thoroughly check product details to ensure accuracy and completeness of the data
Analyze data and identify new trends/patterns
Must be flexible to meet business requirements & work with high priority/visibility English content for other marketplaces (countries) such as US, UK & India and Canada
Job role does not involve core translation on a regular basis, however a business requirement may engage short text translation activities on a need basis
No extensive spoken/written communication in Japanese on a regular basis. Should be competent to independently communicate both written/spoken with stakeholders/clients, in case required
Mandatory: Graduation in any stream
Graduation or Post Graduation in Chinese from any reputed university
Diploma in Chinese along with Graduation in any field
Should have competency equivalent to at least (HSK) Level 4 in Chinese Language
HSK level 4 qualified in Chinese language
Proficient in American English
Candidate must demonstrate language proficiency (English and Chinese) in all the following: verbal, writing, reading and comprehension
Strong working knowledge of basic computer business applications such as MS Word and MS Excel, Outlook
Strong background in web search and familiarity with various ways used for searching for information

Catalog Quality Associate, English Resume Examples & Samples

Approve or disapprove audit entries based on pre-defined guidelines and explain logical reasoning behind approve/reject decision
Browse the site and use search box to look for products
Review Amazon catalog for content quality based on pre-defined guidelines and SOPs
Work with project teams to write and test new SOPs for new audit and data quality management tasks
Good data analysis skills and great attention to detail Oriented
Willingness to work with sensitive issues, including but not limited to
Alcohol, tobacco, weapons and other potentially offensive products

Quality Associate Resume Examples & Samples

You define and deliver the quality goals, strategy and standards considering our cloud development principles
You align with the quality team of the related program
You support the team in quality-related tasks and make sure that those tasks are considered as part of the backlog
You provide transparent status to the stakeholders and proactively take appropriate actions
You get the opportunity to learn relevant business domain knowledge
Good Bachelor degree or above in Finance, Computer Science, Information Systems, or related disciplines
Very high commitment to quality, reliability and a self-motivating style of working
Very good analytical and problem solving skills
Experience in test automation, respectively willingness to build up knowledge in this area
Excellent team player with a strong ability to network and with drive for tangible results
Very good assertiveness to secure that our software achieves the highest quality standards
Willingness and ability to learn new subjects quickly
Fluent in English and German (both spoken and written)
We are looking for candidates who already have initial work experience in a quality role or in the area of business software applications

Quality Associate Resume Examples & Samples

In addition, you will work as a tester in the team
You work as a tester in an agile development team
You contribute to the definition of tests within our Cloud Solution
You will take care that our Cloud solution will achieve the next level of quality
You have the chance to continuously enhance your knowledge and keep up with latest technology trends
In order to deliver first class results, you handle your tasks with enthusiasm and personal commitment. You have the ambition of building future-proof products and using state of the art technologies

Quality Associate Resume Examples & Samples

Complete tasks required to assemble, review, approve and store Change Requests by following current processes and procedures
Perform SOP updates for new or existing codes and process changes
Provide Data Entry into existing and new production systems including PULSE, PLUS and ASC for new or modified drugs/codes
Assist Supply Chain with change activities required for drug shortages and changes including production system updates and team notifications
Drive New Service Code launch activities using CatsWeb to assure launch calendar goals are met
Support Operations projects and process improvement activities
Learn and train others in the new production system, PULSE for data
Bachelor degree and/or one to three years working in a GMP regulated environment. Pharmaceutical manufacturing Quality oversite experience preferred
Proficient in Microsoft Office programs and data entry experience for process programs
Excellent written, verbal and interpersonal skills are required
Must be organized, attentive to detail and have the ability to work independently and collaborate cross functionally

Quality Associate Resume Examples & Samples

Performs physical inspection of in-process and finished product samples as assigned and according to the production schedule
Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements
Becomes competent in at least one process: Weighing, Blending, Granulation, Compression, Coating, Encapsulation, Packaging
Follows internal processes related to controlled substances
Performs GMP related verifications such as line clearances, cleaning, room inspection, and materials
Collects and appropriately labels packaging retain samples, and submits to the archive storage
May execute computer data entries in CME, JDE, LIMS, and/or department databases
Maintains collection of hold time study samples for QC analysis
Collects and retains samples and performs sample evaluation for APR
May backup third party product review/release
Responds to and escalates events identified during production to Quality Management
Participates in investigations with the Rapid Response Team as needed
Performs manufacturing and packaging room inspections and release
Provide quality direction to operations to resolve floor issues, implement corrections, and assure deviations are opened
Collaborates with Manufacturing and Quality partners to identify and implement improvements
Conducts GMP walkthroughs of facilities
Learns how to perform in-process audits to identify adherence to SOPs and BR requirements
Actively participates in training events, and maintains currency with assigned training requirements
Follows all procedures to ensure a safe and compliant work environment
At least 2 years of relevant experience in the pharmaceutical industry
Strong cGMP knowledge in pharmaceutical setting
Ability to communicate and work with teams
Ability to read and interpret SOPs and function within the scope of procedures
Proficiency with basic math skills and basic experience with computers and software applications required
Ability to learn new processes and procedures
Able to communicate effectively with other departments, management and operational personnel
Customer/Stakeholder focused (understands impact of daily work to compliance and overall business)
Proof-reading skills; ability to identify errors
Ability to read and comprehend documentation and requirements set forth in Batch Production Records (BPRs)
10year Background check
Drug testing
Employment references

Intern Quality Associate Resume Examples & Samples

Mapping of the full batch record review. Assess the full batch record review process to define the different criteria and requirements to meet in order to set a shared foundation for full batch record review applicable to all Biogen’s products
Mapping of the manufacturing processes. Assess the manufacturing processes for all Biogen’s products against the filings to streamline search process while searching the information in the batch documentation
Proposing and Preparing unified single checklist for full batch record review. As a result of the mapping preparatory work, define the necessary criteria to build a streamlined and accurate unified checklist applicable to all Biogen’s products
Preparing risk analysis. While reducing the full batch record review, assess the related potential risk. Evaluate and compare the current full batch record review to a potential reduced full batch record review for a streamlined process
Proposing and implementing system to track Batch record update at CMO in compliant and simplified manner. As a result the Quality Engineers will be able to use the implemented tool and this should address the release needs with regards to understanding of the update perform on batch record for all CMOs under External Quality Operations’ oversight

Quality Associate Resume Examples & Samples

Good Bachelor degree or above in Financials, Computer Science, Information Systems, or related disciplines
Excellent end user experience in Finance Solutions
Fluent in Czech (proficient or native level)
0 -10%

Quality Associate Resume Examples & Samples

Minimum Bachelor's Degree in scientific or engineering discipline
GMP experience is a MUST have
Experienced in word processing programs as well as spreadsheet applications

Quality Associate / Specialist Resume Examples & Samples

B.E / B.Tech / M.Tech / MS / MCA fulltime with 65% and above across
Good Communication, Reasoning and Analytical skills
Strong background of SAP Quality processes, Testing, Automation (at-least one automation tool)
High level of commitment towards ownership of product/topic will be the key for success. Strong customer focus required
Experience in manual test execution with standard test design techniques
Sound Hands on experience in designing and developing Test Automation using any of the tools like eCATTs, START, Selenium, QTP
Team player who is looking for new challenges
Constructive Quality Assurance (Quality Risk Assessment, Test Strategy & Design, Test Process, Test Methodology, Test Tool Evaluation & Development)
3 - 7 years of relevant experience in Testing and Quality Engineering

R&D Quality Associate Resume Examples & Samples

Sampling and inspection of raw materials / finished product
Release of packaging areas/equipment prior to the start of operations
Performing in-process sampling/testing
Reconciliation of clinical packaging operations including verification of product accountability calculations
Review of batch documentation, pre and post execution
Review of electronic batch documentation, e-recipes
Review and approval of master label copy and label production runs
Writing and revising of standard operating procedures
Review and approval of clinical shipment and return documentation
Participates and contributes to the process of documenting deviations (writing, performing investigation, etc.)
Conduct effective training on departmental SOPs for both Clinical Packaging and QA
Perform effective internal audits as required
Review of 3rd party / CMO packaging documentation to ensure is meets both internal and cGMP requirements
Acknowledges and adheres to internal/external ethical guidelines, regulations, and policies
Experienced and comfortable working with computers and standard programs such as Microsoft Office, etc
Ability to effectively interact with functional areas outside of Clinical Packaging and PD QA
Ability to offer and implement ideas for continuous quality/efficiency improvements within both Clinical Packaging and PD QA
Ability to anticipate issues, being pro-active in preventing deviations, issues, etc
Experience in working within a pharmaceutical cGMP regulated environment
Bachelor’s Degree or equivalent relevant experience
Strong communication and math skills
LI-RM4

Quality Associate Resume Examples & Samples

Using established inspection/test procedures performs basic incoming inspection/test of components subassemblies and materials (written video etc.) sometimes under the supervision of higher level inspectors and/or technicians
Using established inspection/test/audit procedures performs basic in-process and finished product inspection/test/audits sometimes under the supervision of higher level inspectors and/or technicians
Interprets basic blue prints and drawings
Uses basic measurement and test equipment (caliper micrometers comparators Instron etc.)
Exercise limited judgments in identifying workmanship and material defects; initiates appropriate disposition and corrective action
Maintains records using PC and mainframe terminals to access product information enter data and obtain data
Assists assigned team to maintain Quality System requirements as described within the Quality Manual and other applicable regulatory regulations
May prepare simple reports charts and memos
May perform non-standard inspection and tests with specific guidelines provided by higher level inspectors, technicians and/or engineers

Quality Associate Resume Examples & Samples

Leads ongoing, daily departmental operations
May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner; Interview/hire, evaluate, train and develop direct reports
Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques. Work closely with production supervisors, quality, engineering and other internal groups to accomplish the above and influence necessary actions. Determine the logic, adequacy and effectiveness of processes, systems and related requirements. Develop plans to correct identified risks including areas of non-conformance. Inform management and implement approved corrective action plans
Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills Support process with timely closure of observations/audit items
Oversees audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.)
Participate in QA/QC multi-site projects in the role of contributor, coordinator or lead
Must be a strong team player with good problem solving, and good verbal and written communication skills. Must have the ability to manage people, encourage teamwork and drive decisions
3-5 years experience in Quality with a medical device/Pharma company or other similarly regulated industry

Quality Associate Manager / Manager Resume Examples & Samples

Manage Noncompliance Occurrences (NCOs) and Significant Unplanned Deviation Reports (SUDRs) in the Lifecycle Safety Deviation Noncompliance Quality Assurance (DNCQA) area in the Event Driven Analysis (EDA) database
Review and close completed SUDRs ensuring all text is clear, root cause analysis is comprehensive and all actions to address the root cause will prevent the re-occurrence of the root cause and have been thoroughly executed
Provide metrics and complete trend analysis of DNCQA data at department, functional group and customer level
Support Lifecycle SOP Management, Training Management and Business Continuity Management as needed
Provided dedicated Quality Management support to two or more Lifecycle Safety's functional areas including quality improvement initiatives, quality control processes and responding to and closing out CAPA findings
Assist with customer audits and inspection by regulatory authorities including provide audit conduct training to staff, reviewing project files, facilitating case and report walk through, practice audit presentation with Pharmacovigilance Lead and functional leads, review audit agenda and ensure all staff are prepared and document requests have been completed, attend audit or support audit remotely, review audit reports and assist with audit responses as needed
Provided dedicated Quality Management support to selected projects/customers including contributing and reviewing Quality Management Plans, provide ongoing oversight of compliance and quality goals for project, attend customer meetings, review all NCOs and SUDRs for project and provide DNCQA database metrics
Provide support to Qualified Person for Pharmacovigilance (QPPV) staff including providing information on SUDRS related to their customers along with contributing and reviewing Pharmacovigilance System Master Files (PSMF)
Attend and contribute to monthly Regional Quality Lead meetings
Participate in the review of Planned Deviation Requests
Perform Lifecycle Safety-Assessment of Changes to Regulatory Rules as assigned
Completes ad hoc requests as needed
Work closely with QA on customer audits, internal audits and management of QA quality issues for the department
Sound working knowledge of medical terminology, clinical monitoring procedures (SOPs), ICH-GCP, applicable regulatory requirements, quality management processes
Knowledge of National and International Regulations and Drug Development processes
Knowledge of CRO or Pharmaceutical industry operations
Knowledge of Quintiles corporate standards and SOPs
Good judgement and decision-making skills
Strong computer skills including Microsoft Office and Clinical Trial Management System (CTMS) applications
Ability to travel within the region/country
Ability to lead and motivate a clinical team
Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers
Bachelor's degree in life sciences or equivalent nursing qualification with a minimum of 7 years’ experience in Clinical Monitoring including at least 2 years’ experience in a role equivalent to a Clinical Project Manager/Clinical Team Lead preferably within Quintiles; or equivalent combination of education, training and experience

Quality Associate Resume Examples & Samples

Maintain a high level of personal compliance to the required standards
Perform batch record review
Perform Log sheet review (logbooks, autoclave, cleaning, disinfection, room usage, etc.)
Initiate deviation investigations
Tracking of deviations, CAPA's, metrology discrepancies, facility events, product and environmental investigation and SOP development
Perform facility walkthroughs
Perform documentation issuing (batch records, logbooks, lab note books)
Facilitate the lifecycle of controlled documents (document creation revision, and obsoletion)
Exercise professional written and verbal communications skills in supporting customer and team member needs
Contributor on cross functional project teams
Minimum of Bachelor’s Degree (or international equivalent), preferably in Life Sciences
0-2 years of professional experience, preferably in a regulated industry
Ability to gown and gain entry to manufacturing areas
Ability to work in a manufacturing clean room for extended period of time
Physical demands: While performing duties of job, employee is occasionally required to stand for extended periods of time as well as occasionally required to walk, sit, bend down/ crouch, use hands to handle or feel objects, tools, or controls; reach with hands and arms; talk and hear. Employee must occasionally lift and/or move up to 30 pounds

Quality Associate Resume Examples & Samples

Leads ongoing daily SNC activities; review and verification of SNC package to meet requirements of global policy. Meet with SNC stakeholders and includes weekly meetings with SPO, CCT, and team huddles. Identify and resolve inconsistencies/discrepancy with SNC closures
Leads the SQA Metrics by assisting Baxter IT Department with Trackwise data pull and verification. Prepare and review Metric slide for accuracy and lead the associated monthly meeting
Document any action items and meeting minutes and archive as required
Coordinate reschedule schedule by reviewing and distributing re-evaluation assignments. Monitor re-evaluations and provide on-going support to re-evaluation and Supplier Quality teams
May support internal and external Supplier Quality audit requests as needed
Audit experience a plus and may perform 2- 4 audits a quarter
Understand scientific strategies and be able to invent new processes or new avenues of investigation
Attention to detail and performance of verification activities
Bachelor's degree in science or engineering; advanced degree in the life sciences, physical sciences or engineering
Lead Auditor training, ISO Lead Assessor training, with 2-3 years experience in auditing techniques, interpreting regulations and quality systems is preferred but not required

Quality Associate Resume Examples & Samples

Lead daily departmental activities for areas of direct responsibility
Manage activities of self and Field Action (FA) team members in achieving defined Quality/FA goals in an efficient, accurate, and timely manner. Must be recognized as an expert in their area and demonstrate leadership ability
Lead and facilitate FA review boards, oversee approvals for FA related documents, and drive FAs to closure per approved plans
Lead, participate and draft Global FA Plans with global cross-functional teams for FAs. Interface with internal customers on issues and questions related to the implementation of FAs
Verify FA monthly status reports
Assist the Data Analyst with data collection and report generation
Perform periodic reviews for FA communications and work closely with other FA staff to ensure accurate documentation and data is captured, entered and stored appropriately
Work closely with regional gatekeepers and the franchise to implement and support FA plans, track FA completion and resolve issues to drive FA’s to closure
Present FA and Hold Metrics to management on an as needed basis
Participate in internal and external inspections and assist with implementing solutions to audit findings
Be directly involved in, and where appropriate, lead improvement projects which may include improving current FA processes, data generation, report development and presentation, or improving other quality processes /systems to demonstrate lean competencies
Working knowledge of relevant FCA regulations, i.e. Parts 7, 11, 803, 806, 820, 821
Working knowledge of Medical Products
Knowledge of JDE
Good communication, written and oral skills
Knowledge of regulations outside United States a plus
Self-motivated with the ability to work independently and make decisions
Excellent organizational skills, problem solving skills and attention to detail
Ability to perform multiple tasks simultaneously and work cross-functionally in a highly-matrixed environment
Individual must be able to demonstrate competency in GDP and GMP and have expertise in interpreting regulations
Experience with working in an environment subject to compliance with 21 CFR Parts 7, 11, 803, 806, 810, 820 regulations strongly preferred
3-5 years exp. in Quality with a medical device/Pharma company or other similarly regulated industry

Quality Associate Resume Examples & Samples

Support QIS staff by assisting in the creation of system validation documents, such as authoring technical requirements and report specifications
Perform validation testing through the execution of pre-approved protocols and test scripts
Perform user training as needed on QIS supported systems and processes
As part of the QIS group, assist with identifying and implementing new or reviseddepartment processes and procedures
Develop and maintain SOPs that are consistent and reflect current practices
Work closely with other groups such, as IT, to support QIS projects and daily operations
Ensure software solutions are inspection ready
Minimum of 4 years experience performing the duties and responsibilities listed above
Understanding of the functions and capabilities of data computing

Quality Associate Specialist Resume Examples & Samples

Basic conceptual knowledge and practices associated with Document Review and Product Disposition
Essential Functions
Review and approve Culture Media, Filled Product, and Process Simulation Batch Records
Execute review of electronic Master Batch Records (eMBR’s) utilizing reduced content review of critical steps and parameters as applicable
Review and approve records from supplemental manufacturing operations through RtReports and autoclave logs
Provide Quality review and approval of fill product dilution models
Work with Operations Team and Coaches to resolve issues identified during document review
Present deviations at Event Notification meetings
Perform necessary SAP transactions to indicate task completions to support batch disposition decisions
Additional Functions
Participate in process improvement or learning events, as guided or approved by Quality management
Author, review, and approve SOPs
Direct support of regulatory inspections and audits, as requested
Other duties as requested by Management
Minimum of one year experience in pharmaceutical operations, technical services, and/or quality operations with at least Quality Control, Quality Assurance and/or cGMP experience
Knowledge of CFR, Eudralex and other regulatory guidance specific to the pharmaceutical industry
Experienced in the methods and approaches of conducting quality audits

Quality Associate Resume Examples & Samples

For processes and projects of moderate complexity, perform compliance assessments, make decisions regarding regulatory requirements; ensure adherence to current regulations with little dependence on others
Provide leadership and team participation as assigned for assignments related to quality initiatives and compliance improvements, product transfers, facility expansions, etc
Perform document reviews and made determinations as to whether work performed meets current procedures and regulatory expectations. Communicate and coordinate with other departments as required to resolve issues and compliance concerns detected during review
Conduct risk assessments and take appropriate actions during quality oversight activities (e.g. during review/approval) to ensure adequate controls in relation to the level of product quality, safety and business risks

Senior CMO Quality Associate Resume Examples & Samples

Minimum of 8 years of proven experience in a QA/Compliance related position in the pharmaceutical or life-sciences industry
Minimum 3 years in project related activities (Quality representative/project management…)
Experience with Regulatory submission
Minimum requirement of a bachelor degree in Sciences or Engineering (Chemistry, Biology, Pharmacy, Microbiology, etc.)
Strong track record of identifying, escalating and correcting compliance issues and implementing process improvements
Demonstrated experience working with / preparing Quality agreements and working with / improving Pharmaceutical Quality Management systems
Knowledge and understanding of cGMP (EU / US as applicable) regulations with respect to the production and testing of pharmaceutical and/or biological products as applicable
Experience of blood/Plasma Derived products
Practical knowledge of working with QMS databases like TrackWise and Microsoft Office tools
Clear, demonstrated proficiency in scientific writing
Good interpersonal skills, ability to influence and effectively communicate to all levels internally and externally (CMO management)
Strong process improvement mindset
Excellent time management and strong organizational skills
Proficient in English, Proficient in Dutch is a plus
Individual must be self-motivated, able to work independently
Living the values at Shire is a basic expectation for all Shire employees. Shire expects all employees for live the BRAVE values

Quality Associate Resume Examples & Samples

Cursory review of applications received and movement of this work into the proper team work stream to initiate the new business process
Review and processing of incoming mail requirements for pending cases, attaching proper requirements to individual life files and indexing documents to the appropriate document name
Redirecting to the appropriate processor and answering agent inquiries regarding status of individual case file or process
Mail policy documents as necessary and in accordance with distribution channel requirements
Illustration preparation for policy coordination with Record Center for facilitation of policy mailing

Senior Quality Associate Resume Examples & Samples

Comply with and enforce established GxP (Good Laboratory, Manufacturing, Clinical, and Tissue Practices) as well as Quality Control procedures and standards of operation for US Operations
Responsible for internally auditing and reviewing the company validation program including but not limited to Master Validation Plan, Change Controls, Periodic Validation reviews
Responsible for routinely reviewing and approving company validation documents such as software validations, hardware validations, calibrations, alarm validations, etc
Responsible for reviewing relevant software systems for compliance with 21CFRpart 11 (ISISS, Blue Mountain, Elpro, Qualtrax, LIMS)
System Owner/Administrator for Qualtrax®. Sets up new users, training matrices, workflows. Ensures continuous state of validation
Participate in hosting client audits to assist QA Manager
Participate in internal audits for all US Operations including HQ, partners (RUCDR), Onsites
Participate in supplier audits for all US Operations
Participate in regulatory licenses and accreditations related to US Operations - FDA Tissue license, NRC radioactive license, Japanese FMA license, misc US State tissue licenses, CAP, ISO, etc
Create, coordinate, train employees on, maintain, and audit companywide employee training files
Keep up-to-date in fields of relevant GxP compliance and validation utilizing current literature and attending workshops and seminars
Maintain departmental records/archive
Meet with Director of QA to discuss compliance and GxP policies and procedures, client concerns and annual QA budget development
Work with other functional areas and appropriate resources to develop and implement compliance and appropriate Quality assurance policies
Drive continuous improvement initiatives, develop and monitor effective performance metrics, and coach and develop department leaders
Work with the Director of QA and departmental managers to develop metrics (in support of Quarterly Quality Mgmt meetings) and new business processes that align with a global strategy and achieve consistent high levels of client satisfaction
Implement and monitor processes that ensure appropriate escalation of issues and continuous, appropriate communication of issues across the organization
Attend meetings as required such as in service meetings, committee meetings, department head meetings, etc
Cooperate with BioStorage Technologies staff to achieve goals
Requisition supplies and equipment needed in the department
Perform other duties as directed by the Director of QA
Four-year degree
2+ years’ experience in Quality Control/Assurance
2+ years’ experience with software/hardware validation
Ability to travel occasionally for auditing
Strong analytical skills and the ability to think creatively
Excellent leadership skills and ability to work across organization
Strong communication and interpersonal skills
Experience in GxP facility
Exposure to biological safety policies and guidelines
Demonstrated high level of initiative and ability to work independently
Proven ability to work effectively with teams
Competency with business software systems, Microsoft Office (Word, Excel, PowerPoint, Outlook) Outlook, Word and PowerPoint

Quality Associate Resume Examples & Samples

For processes and projects of low to moderate complexity, perform compliance assessments, make decisions regarding regulatory requirements; ensure adherence to current regulations with little dependence on others
Conduct risk assessments and take appropriate actions during quality oversight activities (e.g. during review/approve/ensure adequate controls in relation to the level of product quality, safety and business risks
BS in related field plus 2 years of relevant experience
Experience in reviewing technical and scientific data associated with pharmaceuticals

Assortment Quality Associate Resume Examples & Samples

University graduate with relevant bachelor degree
Preferably 1 year of analytical work experience
Self-motivated, hard-worker, with problem solving skills
Pro-activeness and ability to work under pressure
Outstanding communication and interpersonal skills
Fluent in English and Vietnamese language
Excellent knowledge of Microsoft Office suit (Word, Excel, PowerPoint)
Enthusiasm for e-commerce and its opportunities
Prior knowledge in project management advantageous
Knowledge in Intellectual Property and Product Quality Control advantageous

Quality Associate Resume Examples & Samples

Working knowledge of US Drug Product GMP requirements and associated guidelines
Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues
Ability to increase others knowledge of US end European GMP regulations and guidance
Experience in administration of quality systems for drug product manufacturing and quality control operations
Minimum of 2 years’ experience in a Quality Assurance role in the pharmaceutical industry

Quality Associate Resume Examples & Samples

Provide support to department inspection positions assuring understanding and recognition of defects
Interact with key stakeholders in the identification and resolution of product quality problems
Assure quality process inputs are documented in standard operation sheets
Participate in the Customer Complaint Analysis
Perform incoming inspection of Just in Time (JIT) product to company standards
Perform QC level inspection to finished good product
Support Jasper operation employees as needed to interpret specifications and solve problems
Support the Jasper Quality System by performing tasks to ensure compliance and initiate continuous improvement of the system
Periodically review specifications and Standard Operating Sheets (SOS) etc. for accuracy and revisions
Perform layered process audits as scheduled and work towards resolution of open item
Perform root cause analysis and participate in corrective action processing of quality issues
Provide support to floor associates assuring production goals are met
Provide training/coaching on quality related issues to Jasper production associates and management
Lead and/or participate in Kaizen improvement events
Exhibit and enforce the MBCI Safety Awareness culture
Consistently demonstrate the Six for Success: be trustworthy, commit to your team, listen to understand, serve your customer, deliver the result, and prepare and plan
Perform other duties as may be assigned at management’s discretion
High school diploma or GED equivalent is minimally required
Experience with quality systems is preferred
Knowledge of MBCI quality standards and specification is preferred

Quality Associate Resume Examples & Samples

Degree in Science or equivalent
Related working experience in Quality Assurance & Quality Control
Possess good communication & interpersonal skills1700176361W

Quality Associate Resume Examples & Samples

University degree in computer science, mathematics, engineering or a related field
Proven programming skills and experience in implementing automated tests
Excellent German and English language skills - written and verbal
Experience with Agile and Scrum Methodology
Knowledge and hands-on experience in object-oriented programming and in design patterns
Ability to independently identify and solve problems at hand
Strong analytical skills, as well as excellent interpersonal and communication skills
Interest in learning new technologies and in personal growth
High ambition, drive for and focus on results and execution
Intercultural awareness
Working knowledge in all aspects of the software development lifecycle
Background in using master data objects in standard business processes
0 - 10%

Development Quality Associate Resume Examples & Samples

Implement and maintain the local Quality System in the areas of GCP and GPvP, in accordance with the Novartis Quality Manual and the CPO Quality Plan
In cooperation with local DRA and DS&E, keep abreast of regulatory requirements, and update local management and Pharma Development MA/CPO QA on the possible ramifications of regulatory changes and impact to Clinical Development, MA and PV processes
Conduct proactive in-process quality and compliance review through monitoring of adequate Key Quality Indicators (KQIs) and assure that gaps are addressed appropriately in order to mitigate risk
Conduct vendor assessment and/or qualification visits for locally outsourced clinical development, MA and pharmacovigilance (PV) activities. Ensure the ESP selection process properly followed at the CPO
Partner with Pharma Development QA in the preparation, execution and follow-up of audits on clinical development activities. Together with the auditees, determine root causes for country-specific major and critical audit. Verify that appropriate corrective and preventive actions are implemented on all major and critical audit findings
In cooperation with the local GMP QA Unit ensure analysis, assessment and resolution (including CAPAs where indicated) of issues with common interfaces
Participate in PH Dev QA investigation activities, as appropriate
Ensure, where appropriate, interface/communication with authorities for any GCP/PV related activity (e.g. local Health Authority [HA] inspections)
Ensure CPO readiness for all GxP regulatory inspections
Provide support prior to, during and after HA inspections of the CPO, investigational sites or external service providers, as applicable, together with the Novartis inspection lead. Ensures that responses to local Health Authorities have been submitted, commitments have been met and relevant CAPs have been completed/closed
Ensure conduct of adequate training at the CPO for all GCP and GPvP activities by defining, planning and supporting training activities
Ensure that the clinical and PV computerized systems are adequately identified during the High Level Risk Assessment for GXP relevance to enable their validation where required
Degree in Life Sciences or related fields
Ideally a number of years’ experience in the pharmaceutical industry in a relevant field such as quality assurance, registration, clinical development or a directly related area

Quality Associate Resume Examples & Samples

Performs standard tests on assigned product line production batches and on some incoming raw materials as needed, ensuring the meeting of PolyOne and the customer’s specifications
Acts as a technical resource to production addressing issues related to production batches
Recommends to production and may develop adjustments to batches to meet specifications
Records test results in SAP. Maintains reference files
Completes and maintains all required paperwork, records, documents, etc
Ensures all gauges and test equipment are verified
May participate in investigations of complaints and corrective actions as needed
Completes and sends documentation to customers (i.e. COA)

Quality Associate Resume Examples & Samples

This position is responsible for processing complaint files and/or MDRs
Responsible for managing a complaint file and/or MDR workflow, which includes performing the daily tasks associated with processing these files
Participate in continuous improvement efforts and projects
Assist in developing plans to investigate identified risks
Interpersonal skills Verbal and written communication skills
Ability to prioritize and multitask
Proficient with computers
Writing Sample required
Data Entry Proficiency (30wpm with 90% accuracy)
Excel 2010 experience (Pivot Tables and V-Look ups)

Quality Associate Resume Examples & Samples

To ensure that all processes are performed in accordance with cGMP
To ensure services and processes perform in the company are in compliance with local regulatory and policies
Document control management, in alignment with Network Quality standards
Perform pre and post review of production batch records and label printing records
(if applicable)
Conducts internal audits according to SOP requirement and assist in regulatory, supplier and client audits
Management of non-conformances (deviations, complaints and quality investigations) and related corrective and preventive actions
Write and/or review problem report to ensure the quality of the report produced
Assist in managing the QA/GMP training of employees across the company
Responsible for the release of client supplied materials and Fisher supplied materials
Approval of component and material specifications
Perform periodic checks on the accuracy of picked drug supplies against client orders and shipping distribution documents
Responsible for in-process check for Just-In-Time Labeling and in-process inspection during production job runs
Bachelor's degree in life sciences or related medical/scientific field
Previous working knowledge in the pharmaceutical/medical/healthcare settings in the field of quality assurance and regulatory affairs; Licensed Pharmacist preferred
Good organizational skills and the ability to manage multiple tasks
Computer Literate
Able to manage complex problems/projects by exercising independent decision making and analytical thinking skills within generally defined practices and policies

100

Quality Associate Resume Examples & Samples

Lead ongoing daily department activities across all shifts for the Biochemistry Laboratory including supervision of assigned personnel and when required assist other Quality areas in the successful performance of these activities
Manage the overall logistics of the Biochemistry Lab across all shifts, including scheduling (e.g. final containers for LA/RLDD Release, Stability, special projects), Use Lean tools and make recommendations to improve operational efficiency and throughput
Provide timely reporting of performance metrics. Develop, establish and monitor systems that focus on key indicators of laboratory control. Present department metrics to management through routine operating mechanisms
Be directly involved in and, where appropriate, lead multiple process/product improvement projects. These projects may be executed through CAPA, QWT, Kaizen, or other focus groups, design of experiments, studies, data generation and analysis, report preparation, presentations, and/or change control
Primary audit escort for the Biochemistry Laboratory. Lead laboratory audit ready status efforts in understanding FDA, Shire, and other regulatory and quality requirements. Maintain a high level of expertise in current regulatory requirements and serve as a laboratory resource for compliance to these requirements
Lead in the development of customer awareness and support activities for Biochemistry, and assist and drive such activities throughout the shifts
Operational liaison with various customers (e.g. Manufacturing BUs, RLDD, Hayward, etc)
Make appropriate staffing recommendations through effective interviews, performance appraisals, and by driving appropriate accountability and feedback. Ensure employees have development plans
Will be required to perform the operational responsibilities of the Biochemistry Laboratory Manager in his/her absence
Prepare, review and revise, as required, CTPs and SOPs. Write memos, reports, protocols, CPAs and other appropriate documentation as they pertain to Biochemistry operations and procedures
Drive Major Changes, as required, through Plant or Divisional Quality Systems
Lead Plant-wide initiatives as assigned
Drive Lean principles such as 5S throughout daily work activities
May perform removal of hazardous waste
Bachelor's degree in Chemistry, or biological science with Analytical Chemistry or Laboratory coursework with 5+ years of relevant experience, including 3+ years of Quality experience
Or-
Master's Degree in Chemistry, or biological science with Analytical Chemistry or Laboratory coursework with 3+ years of investigational experience

101

Quality Associate, Days Resume Examples & Samples

Will assist the Quality Manager with all quality operations and responsibilities at the Pain Management facility
Ensure compliance to procedures and address non-compliance issues
Will assist in the collection and compilation of data for submission of all DEA related reports which include ARCOS reports, Procurement Quota Requests and Year End Reports
Will perform review of quality related documents generated at the facility
1 - 3 years experience in Quality, Operations, or related field in the healthcare industry. BS in science or related field is desired
Basic PC skills including MS Word and Excel

102

Night Shift Quality Associate Resume Examples & Samples

Purchased material quality planning, evaluation, and control
Product and process quality evaluation and control
Assure Calibration of measuring instruments
Participate in the maintenance of the manufacturing quality analysis
Perform internal audits as prescribed within the MBCI Business System
Periodically review specifications, drawings, work instructions, etc. for currency and accuracy
Perform product audits as assigned
Obtain corrective action by appropriate position; follow-up and determine effectiveness of action plans
Support Decora’ employees as needed to interpret specs and solve problems
Support the Quality System by performing tasks to ensure the compliance and continuous improvement of the system
Provide accurate quality information feedback
Provide training/coaching on quality related subjects to Decora’ personnel as needed
Must be a team player with strong communication skills
Must have the ability to actively lead and participate in problem solving
Ability to maintain the professional competence, knowledge, and skill necessary for the satisfactory performance of all assigned responsibilities
Knowledge of Word, Lotus, and Excel beneficial
Two years experience within a manufacturing environment preferred

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