Supervisor, Quality Resume Samples
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Supervisor, Quality Resume Samples
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JA
J Auer
Joel
Auer
8825 Kyra Crossing
Detroit
MI
+1 (555) 134 0222
8825 Kyra Crossing
Detroit
MI
Phone
p
+1 (555) 134 0222
Experience
Experience
Detroit, MI
Supervisor Quality
Detroit, MI
Schmitt, Ruecker and Bechtelar
Detroit, MI
Supervisor Quality
- Supervises, develops work schedules and assures proper work load distribution for a 24/7 planning schedule
- Perform verbal and written tie-in/turnover indicating status of work progress
- Provide inspector training and certification to include classroom training, OJT, testing, and return to service authorization letters
- Work with Manufacturing and other departments to solve and prevent production/quality related problems
- Responsible for the GMP compliance of all functions and processes of the areas in charge and responsible for continuous improvement
- Responsible for overseeing compliance in batch process. Provides as technical expert for area
- Assures employees are trained and assigned to perform necessary operations including conformance to quality specifications
Chicago, IL
Supervisor, Quality
Chicago, IL
Monahan Inc
Chicago, IL
Supervisor, Quality
- Supervises, develops work schedules, and assures proper work load distribution for a 24/7 planning schedule
- Perform compliance metrics and drive improvement on those metrics
- Develop, analyze, validate, integrate, and manage aircraft level mass properties
- Work on process improvement projects
- Responsible for training, development and performance evaluations for direct reports
- Assists with conducting and developing standards and quality process training
- Coach/develop the integrated Operations Unit and Quality functional teams
present
Chicago, IL
Supervisor, Quality Review
Chicago, IL
Abbott-Kertzmann
present
Chicago, IL
Supervisor, Quality Review
present
- Makes or recommends employment, termination, and performance improvement plans, and conducts performance and salary reviews
- Communicate well with Director, Interdepartmental Management, Senior leadership, and assist management with additional duties or projects that are assigned
- Work to insure the validation and timely submission of compliant insurance paper work to the clients Registered Principles and commission processing teams
- Makes recommendations for team process improvement
- Ensures audit staff understands current information and updates on claims payment, provider / contract configuration, customer service, and benefit configuration processes
- Evaluates performance and recommends merit increases, promotions, and disciplinary actions, assists in interviews, trains, and orients staff
- Provides and/or oversees Quality training and educational development
Education
Education
Bachelor’s Degree in Business
Bachelor’s Degree in Business
Seton Hall University
Bachelor’s Degree in Business
Skills
Skills
- Attention to detail and the ability to work in a fast paced constantly changing environment
- Ability to independently manage projects and corrective actions
- Sound analytical/statistical skills and technical writing capability
- Serve as project Quality Manager on small to medium sized projects, if necessary
- Proficient with Microsoft Office Applications (i.e., Word, Excel, PowerPoint)
- Good understanding and experience in compliance to ISO13485 and FDA 21CFR820 regulations
- Maintain relationships with key internal and external Clients and external Quality community
- Effective communication skills both written and verbal
- Communicate effectively with all labor grades, and contribute ideas that stimulate positive direction of business line personnel
- Typically manage personnel and provide an environment for the development and professional advancement of staff members, including on-the-job and formal training and development opportunities ,and timely performance feedback
15 Supervisor, Quality resume templates
Read our complete resume writing guides
1
Supervisor, Quality Review Resume Examples & Samples
- Work to insure the validation and timely submission of compliant insurance paper work to the clients Registered Principles and commission processing teams
- Prioritizes, assigns and balances on-going Quality team workload among staff to maintain service standards
- Makes or recommends employment, termination, and performance improvement plans, and conducts performance and salary reviews
- Provides and/or oversees Quality training and educational development
- Makes recommendations for team process improvement
- Audits and reports on the Team’s work activity and error rates to ensure service standards are being met
- Work with appropriate internal and external counterparts to respond and resolve escalated Quality reviews or Licensing issues
- Handle Quality Reviews in unique and/or complex situations
- Completes projects as requested by Management
- Proven ability to lead and direct the work of others and possess a degree of creativity and latitude in performance of tasks
- Effective interpersonal and written communication skills
- Ability to provide excellent customer service to both internal and external customers
- Ability to perform a variety of tasks and able to rely on experience and judgment to plan and accomplish goals
- Ability to prioritize and accomplish multiple tasks
- Ability to work in a self-directed fashion
- Must be detail oriented and analytical
- Minimum 4 year experience in life insurance with emphasis in a compliance role
- Extensive knowledge of new business insurance concepts, practices, and procedures including replacements (1035 and New York Reg 60), suitable sale to minors and seniors, variable life insurance
- Basic knowledge of state life insurance license and appointment
- Basic knowledge of life insurance commissions process
- Understanding of HIPAA and HITEC as they relate to the Life Insurance Industry
- Ability to read and understand life insurance illustrations and/or in-force illustrations from the insurance companies marketing departments
- Experience with PC's in a Windows environment, Microsoft Excel to build reports using Pivot Tables and Vlookups functions, SharePoint and InfoPath
2
Supervisor, Quality Review Operations Resume Examples & Samples
- AAS in Nursing
- Current licensed LPN or RN with 4–6 years of clinical experience in critical care or med-surgical experience
- Advanced clinical assessment skills
- Ability to proficiently read and interpret medical records
- Knowledge of NCQA/URAC standards
- Knowledge of HEDIS/QARR/Star specifications
- 5 year’s experience in a managed care environment
- Prior management experience
3
Supervisor Quality Resume Examples & Samples
- Provides leadership, support, and guidance to all shop floor activities including communication of quality events to management
- This position will develop, Performs or supports activities related to In-Process Testing, AQL’s, and/or Investigational Protocol Execution
- They will provide support to Investigations and/or CAPA
- They will evaluate non-conformance investigations provided by the operations assuring that all appropriate investigation steps were conducted and that appropriate corrective actions were devised where applicable
- Provide approval to manufacturing and packaging operations to begin production activities
- Conduct in-process cGMP compliance audits of manufacturing and packaging operations
- Approve master batch and packaging records assuring compliance to McNeil standards
- Approve SOPs for the Fort Washington site
- Provide support to all Batch Record Review/ Product Disposition activities in the plant. Provide leadership and guidance to QA Retain sample management and QA label control programs
- A minimum of bachelor’s degree is required. A focus degree in Science or Technical field is preferred
- A minimum of 4 years in Pharmaceutical or highly regulated industry in quality with proven success in quality systems/compliance improvement is required
- Active cGMP Interpretation and Application experience is required
- Project Management, MBRs, Change Controls experience is preferred
- Process and Systems experience, especially with SOPs, Non-Conformance Investigation Documentation, and CAPA is required
- Computer System experience with SAP and LIMS preferred
- Validation experience is preferred.Quality Assurance
4
Supervisor Quality Resume Examples & Samples
- Supervises, develops work schedules, and assures proper work load distribution for a 24/7 planning schedule
- Responsible for team meeting batch release quality and timing requirements
- Work with Manufacturing and other departments to solve and prevent production/quality related problems
- Responsible for the GMP compliance of all functions and processes of the areas in charge and responsible for continuous improvement
- Participates in weekly MRB meetings
- Assume the responsibility for the Environmental Health and Safety procedures awareness and compliance within the respective area
- Support Operational Excellence and WISE OWLS initiatives
- SME for CQMS; extended regionally
- 4-6 direct reports
5
Supervisor, Quality Resume Examples & Samples
- Supervise Quality Assurance inspection personnel for Edwards THV Irvine
- Manage processing, disposition and release of MRB product per internal procedures
- Responsible for ensuring adherence to quality system requirements compliance to internal policies and external regulations (ISO 13485, 21CFR 820, 21CFR 11, OSHA, etc.)
- Plan resource requirements and scheduling personnel to meet production requirements and makes hiring decisions for new personnel
- Select, develop, and manage performance of the Quality staff supporting multi-line and mixed-model operations
- Provide support for Quality Engineers, Operations, and other support functions
- Develop, maintain and implement training plans for all personnel. Conduct training and certification activities as required
- Monitor the production operations through coordination of production audits, completion of product testing, and maintenance/review of documentation
- Participates in or leads investigations related to process deviations, and non-conformances, as well as participate in CAPA activities
- Support New Product Development with inspection of new designs in development
- Set department goals/expectations, provide performance feedback to employees and manage performance
- Provide feedback, including escalating testing issues and changes in the final devices and raw materials to higher levels (e.g. Engineering Support, Product Line Team members, etc) for assessment and correction. May provide recommendations to Engineering staff
- Maintain working areas in compliance with Quality System requirements, including materials identification and segregation, equipment validation, calibration, line clearance, etc
- Supports team to identify, evaluate, prioritize and implement Lean manufacturing methods, processes and flow to meet continuous improvement goals
- Effective communication skills both written and verbal
- Ability to independently manage projects and corrective actions
- Proficient with Microsoft Office Applications (i.e., Word, Excel, PowerPoint)
- Requires strong team building and talent management skills
6
Supervisor, Quality, Global Resume Examples & Samples
- Develop, analyze, validate, integrate, and manage aircraft level mass properties
- Analyze drawings to calculate and capture the weight delta associated to Flight Test Modifications
- Prepare and present mass properties data, trends, comparisons, and analyses
- You must have had previous experience working in a manufacturing environment in a quality capacity
- You must be comfortable working independently and as part of a team
- You must have demonstrated leadership skills combined with excellent communication and interpersonal skills
- You must be flexible to work shifts
7
Supervisor Quality Resume Examples & Samples
- Current US Citizen and ability to attain US Department of Energy “Q” level security clearance
- Bachelor's degree in Operations, Supply Chain Management, Business or related technical field
- Minimum of 3 years’ relevant experience in a related role (mechanical, electro-mechanical or electronic quality, quality inspection, test and/or manufacturing fields)
- Must be able to work any shift
- Established and working knowledge of current quality assurance/quality inspection processes
- Understanding of Manufacturing Execution Systems (MES)
- Familiarity with Material Resource Planning (MRP) applications
- Ability to access, understand, interpret data and act in a timely and appropriate manner
- Experience identifying and acting on continuous improvement initiatives
- Six Sigma Green Belt certified. History of applying standard Six Sigma tools
- Familiar with principles of the Honeywell Operating System (HOS) or Lean Principles
- Experience interacting with union employees and representatives
- Evidence of ability to coach, mentor, develop and discipline people
8
Supervisor, Quality Resume Examples & Samples
- Review, validate, audit, integrate, and manage structural and systems component mass properties
- Support weighing activities on the Final Assembly Line
- You must possess a Diploma or University degree in business or related field
- You must have had previous experience working in a manufacturing environment in a quality capacity of a minimum of 5 years
- You must be self-motivated and willing to take the initiative
- You must have led a team in an unionized environment
- You must be flexible to work shifts in an environment operating 24/7
9
Supervisor Quality Silao Resume Examples & Samples
- Coordinates project related Q-activities during the development phase
- Determines project related Customer Q-requirements
- Responsible for preparation of D-FMEA
- Coaching of supplier APQP process
- Ensure knowledge transfer from Kautex DVP to supplier DVP
- Responsible for SC/CC agreements Customer/Kautex, Kautex/supplier
- Responsible for PSW agreement Customer/Kautex, Kautex/supplier
- Coordinates PPAP releases for suppliers
- Responsible for 2-Day-Production / RatR, Kautex - suppliers
- Supplier Audits
- Supports Q-activities during production phase (specially problems with purchased parts)
- Permanent member of Kautex Program Team
- Feeds Lessons Learned process
- Coordinates preparation of project related DVP
- Coordinates preparation of project related P-FMEA
- Coordinates preparation of prototype, pre-launch, launch and production control plan
10
Supervisor Quality Resume Examples & Samples
- Perform supervisory responsibilities for assigned employees and area(s), for example, performance review and feedback, opportunities for professional development and growth, and personnel decisions concerning hire, fire, disciplinary issues, and salary adjustments
- Lead, direct, and coach aircraft inspectors in performing aircraft heavy maintenance, line maintenance, and repair and overhaul quality control and inspection activities
- Assign inspectors in the areas of aircraft, parts, and NDT inspection based upon skill, experience, and qualification of individual team members
- Perform verbal and written tie-in/turnover indicating status of work progress
- Provide inspector training and certification to include classroom training, OJT, testing, and return to service authorization letters
- Develop, administer, and maintain the written practice procedure for the qualification and certification of nondestructive testing personnel including serving as certifying authority
- Review and resolve controversial and/or circumstantial write-ups including presentation to higher authority
- Oversee periodic audits of aircraft records and logs to ensure compliance with applicable FARs
- Oversee records filing system for each aircraft, for example, aircraft flight log, airframe log book, engine log book, component records, delivery records, certificate of airworthiness, airworthiness directives, and radio license
- Serve as a point-of-contact for customers (including FAA as applicable) concerning maintenance operations, for example, compliance, conformance issues, and overall relationship
- Review, develop, and implement recommendations for aircraft maintenance concerning, for example, proposed/published manufacturer’s recommendations, service bulletins, and FAA airworthiness directives
- Review, develop, and implement recommendations for associated technical operations manuals, for example, minimum equipment lists (MELs), maintenance procedures, and quality policy manuals
- Assume the responsibility of and act as acting QA Manager during absence of QA Manager as required by assigned site
- Serve as the primary point-of-contact for the FAA and maintaining the overall relationship with other regulatory agencies as required by assigned site (occasional)
- You have an A&P certification
- Typically 6+ years’ experience in quality assurance within aerospace industry, which must include 2+ years of supervisory or lead experience either in aircraft maintenance or quality
- Working knowledge of applicable Federal Aviation Regulations, including but not limited to, part 21, 25, 43, 65, 91, 121, 135, and 145
- You have interpersonal skills necessary to develop and maintain effective working relationships with our customers, regulatory agencies and representatives, suppliers, and all levels of management team and other departments and sites throughout Bombardier Aerospace
- Working knowledge of computer skills including but not limited to SAP, Lotus Notes, Microsoft Office software (Work, Access, Excel and PowerPoint)
- Demonstrated leadership to train employees in the performance of duties in area of specialization
- Ability to handle multiple tasks, prioritize and organize effectively
- You have a bachelors in aviation management or related field (preferred)
- Inspection Authorization (AI) Certificate (preferred)
11
Supervisor, Quality Resume Examples & Samples
- Supervise staff in connection with all product control, batch record review and responsible for product conformance
- Responsible for overseeing compliance in batch process. Provides as technical expert for area
- Implement quality systems to reduce record review time and increase timely response to customer requirements
- Responsible for human resources within the department, including periodic evaluations against plans and standards, training, direction and addresses personnel issues
- Participates in MRB and Quality Indicator meetings as needed
- Support Operational Excellence and EHS initiatives
- Work on process improvement projects
- SME for CQMS
12
Supervisor Quality Detroit Resume Examples & Samples
- Organize job assignment for department's quality functions
- Ensure that for quality technicians, all HR development requirements and activities are in place and gaps closed as necessitated
- Assist in ensuring that Customer's and Kautex' requirements are addressed and satisfied
- Assist in the management of quality-related issues with customers
- Ensure the implementation of adequate preventive and evaluation tools within the technician function, e.g.: Product inspection and testing, FMEA, Poka Yoke, etc
- Assist in the management of Non-Conforming Products and controlling the “Quarantine” area
- Maintain control of internal/external quality-related documents and records
- Assist with ensuring all specific issues regarding EHS and quality are implemented and observed in line with OHSAS 18001 and TS 16949
- Communicate and promote cooperation with all other Kautex Plants / Departments in order to share experiences and achieve quality targets
- Ensure that processes needed for the QMS are established, implemented and maintained as set forth by quality manager
- Promote awareness of the importance of the key quality-related jobs
- Ensure knowledge about and compliance with Customer Specific Requirements throughout your team and if necessary define training measures
- Quality certification, Associate Degree, Bachelor's degree, Engineering or comparable education
- Certified Internal Auditor by KAUTEX or external body or willing to become certified
- 3 years professional experience in automotive industry is preferable
- Product knowledge is important
- Knowledge of applicable customer-specific requirements
- Knowledge in statistics, FMEA, Control Plan APQP, PPAP, SPC, MSA, DOE and product and process capability
- Knowledge of manufacturing techniques and business systems, e.g.: 5S, standardized work, Kanban, visual management
13
Supervisor, Quality Resume Examples & Samples
- Supervise a staff of Quality Inspectors and Quality Analysts responsible for quality assurance activities within the QA Receiving & Inspection group
- Manage activities of self and direct reports in achieving defined goals in an efficient, accurate, and timely manner
- Responsible for training, development and performance evaluations for direct reports
- Manage raw material related issues and mitigate raw material risks to ensure no interruption to manufacturing operations
- Responsible for review of quality related documentation associated with QA Receiving/Inspection operations including conducting and reviewing/approving nonconformance/CAPAs and determining disposition status of materials
- Lead ongoing daily departmental activities for areas of direct responsibility and when required assist other Quality areas in the successful performance of these activities
- Responsible for Responsible for conducting document changes (SOPs, Forms, checklist, etc.)
- Able to apply problem solving tools and methods to coordinate and/or lead investigation teams. Lead investigations (i.e. CAPA) for process failures within respective areas
- Acts as a change-agent and drives continuous improvement activities
- Works closely with Manufacturing, other Quality Assurance departments, and other support groups (e.g., Logistics, Warehouse, etc.) in the areas of cGMP compliance and quality systems. Provides direction in the event of receiving/inspection incidents that may potentially affect quality or compliance
- Provide on-call support, as needed
- Maintain and update departmental business indicators
- Serves as subject matter expert and interface with inspectors during internal, corporate and regulatory inspections in areas of expertise
- Serve as Quality Assurance representative on facility projects and own project milestones and implementation actions
- May perform other duties as assigned
- General knowledge of manufacturing processes, laboratory operations, and/or critical systems required
- Proficient in statistical tools associated with receiving/inspection processes
- Strong verbal, written and oral communication skills. Able to present business indicators to Senior Management
- Able to present areas of responsibility to inspectors/auditors during inspections
- Must be able to navigate, conduct searches, and fill on line forms on Personal Computer for the purposes of training, performance management, and self-service applications
- Proficient in problem solving through the use of continuous improvement tools; certification desired in ASQ, Green Belt, Lean, or equivalent
- Demonstrate proficiency in multiple quality systems including exception management, change control, document control, inspection, release, etc. with strong decision making skills utilizing risk management
- Lead multiple tasks/projects within timelines
- Demonstrates leadership by identifying improvement opportunities and implementing solutions
- General knowledge of cGMP (US, EU, Canadian, Japan) required
14
Supervisor, Quality Resume Examples & Samples
- Implement and supervise technical quality (i.e., adherence to client, regulatory agency, and company requirements), and help to maintain harmonious client relations
- Communicate effectively with all labor grades, and contribute ideas that stimulate positive direction of business line personnel
- Serve as project Quality Manager on small to medium sized projects, if necessary
- Maintain relationships with key internal and external Clients and external Quality community
- Typically manage personnel and provide an environment for the development and professional advancement of staff members, including on-the-job and formal training and development opportunities ,and timely performance feedback
- Job related technical knowledge necessary to complete the job
15
Supervisor, Quality, Global Resume Examples & Samples
- Ensure functional role is integrated into Operations Unit resulting in a one-team approach
- Coach/develop the integrated Operations Unit and Quality functional teams
- Utilize AES and Problem Solving techniques to ensure best practice and continuous improvement in Quality deliverables
- Maintain an equitable work environment
- You have understanding of Quality Management Systems
- You have understanding of Change Management process
- You utilize the appropriate resources to solve day-to-day problems, react quickly to unforeseen events
16
Supervisor, Quality Laboratory Resume Examples & Samples
- Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Manufacturing, Quality, Engineering, etc)
- At least 3 years’ experience in the Pharmaceutical industry or a similar operating environment which includes significant leadership roles with experience in a front-line supervisory role in operations environment
- Desirable evidence of Continuous Professional Development
17
Supervisor Quality Operations Resume Examples & Samples
- Supervise the QA Auditors
- Schedule auditing assignments to staff
- Monitor the production processes and ensure consistency of procedures
- Involvement in decision making to stop production if quality standards are not being met
- Revise Standard Operating Procedures and associated forms when needed
- Reviews batch records and release incoming packaging components
- Annual Report Compliance/Annual Product Review
- Oversee the automated inspection of finished products
- Authorize to ship finished products under quarantine
- Responsible for Mean Kinetic Temperature Calculations sign off
- Maintain retain samples for all products
- Special projects and other assignments as needed
- Evaluate personnel requirements of the quality assurance department
- Able to use personal computer and standard office equipment such as fax and copy machines, calculator, and printers. Aptitude to learn computer programs as needed (i.e. Word, Excel) in addition to other business applications
- Strong verbal and written communication skills. Resourceful and well organized
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
18
Associate Supervisor, Quality Resume Examples & Samples
- Analyzes data and puts corrective actions into place
- Reviews quality reports
- Provides immediate supervision to inspectors, checking work at frequent intervals
- Confers with management and production to determine support quality goals
- Demonstrates detailed expertise in complex functional/technical area or broad breadth of knowledge in multiple areas
19
Supervisor, Quality Review Resume Examples & Samples
- Supervises assigned personnel to ensure audits are conducted using related guides and training materials
- Monitors audit priority, workflow, and schedule to ensure productivity standards are met
- Monitors employee performance to include but not limited to production and quality monthly and annually
- Approve time cards; coordinate time- off requests while evaluating business needs
- Ensures audit staff understands current information and updates on claims payment, provider / contract configuration, customer service, and benefit configuration processes
- Acts as a resource to auditors and internal business partners for the purposes of training or trouble shooting for continuous process improvement
- Effectively plan staff responsibilities and manage activities daily, utilizing staff resources to meet departmental goals including seeking out assistance when needed
- Review monthly scorecards for accuracy and low / high performance trends
- Stay abreast of industry standards, CMS guidelines and ongoing trends that would impact the department
- Communicate well with Director, Interdepartmental Management, Senior leadership, and assist management with additional duties or projects that are assigned
- Supports staffing initiatives by screening, interviewing and selecting new employees for current job vacancies
- Bachelor’s degree in Healthcare Administration or a related field required or equivalent work experience
- 2+ years of healthcare experience, including 1+ year of supervisory / lead experience
- 5+ years of medical claim processing experience in a managed care operating environment
- Must have sound knowledge of managed care operations, medical terminology, referral process, claims process, and ICD-9 and ICD10 CPT coding
- Knowledge of Medicare processing guidelines
- Working knowledge of Microsoft Office applications, including Excel
- Ability to exercise initiative, problem solving, decision-making
- Ability to establish priorities and coordinate work activities
20
Supervisor Quality Measurement Resume Examples & Samples
- Actively work within Rio Tinto’s Safety Policies and Procedures and support team members in the same manner to achieve and maintain zero injury and occupational illness
- Maintaining adequate operator coverage on all shifts, utilising support from other leaders to facilitate gaps when required
- Monitoring the sampling performance throughout the shift and ensure compliance to escalation processes is maintained
- Monitoring and inspecting sample stations (robotic or manual) throughout the shift and report anomalies superintendent
- Maintaining regular reporting to Dynamic Scheduling and Technical Marketing teams on sampling performance with reference to equipment availability and grade non-conformance
- Applying working knowledge of all laboratory instrument principles in order to assist the shift technician to fault find relevant instrumentation
- Minimum Cert IV in Laboratory
- C class driver’s license
- Laboratory experience
- Similar experience in a previous role
- Previous robotic systems experience
- Forward thinking and value orientated
21
Supervisor, Quality Resume Examples & Samples
- Ensure that all team members understand their role and performance requirements in achieving the Operations Unit plan and provide feedback
- Ensure the right resources are available to meet projected workload delivery on quality, cost and schedule
- You have in depth knowledge and experience in quality budgeting control; manufacturing; scheduling
- You have previous experience in Collective Agreement administration
- You possess the following: ethics, integrity and honesty, respect for others, cooperation, be motivated to get things done, be able to express ideas logically and coherently, possess a positive attitude, be able to overcome obstacles, assume full responsibility
22
Supervisor, Quality Resume Examples & Samples
- Understand current requirements of Local Regulatory Agencies (MOH’s), and ensure compliance to all applicable quality standards and regulatory requirements
- Supervise the mainly activities of the quality system to assurance the compliance with the standards and internal policies, including suppliers and distributors, and liaising with other functional areas as appropriate in the execution of these tasks
- Coordinates and serves as a catalyst to ensure the compliance with J&J policies of the Quality personnel at the local warehouses and other areas
- Perform follow up to determine compliance with regulations and quality standards and identify, correct and eliminate compliance gaps
- Coordinate training among the company and clients regarding to Quality System
- Ensure the proper deployment of the procedures applicable to each area (warehousing, complaint management, field actions and recall management, etc)
- Monitor deviations of quality system for trending purposes in order to take corrective and preventive actions
- Ensure all Compliance Alerts (Stop Shipments, Recalls and any other Field Action) are under control according to current procedures and the information requested by the Originating Companies is provided in a timely manner
- Ensure the deployment of standars and the activities related with training, plans, audits and schedules
- Ensure complaint and Post market surveillance program execution ensuring the timely closure of product related complaints cases, quality, and immediate escalation
- Manage the overall corrective action and preventive action (CAPA) and risk management. Ensure the tracks quality investigations and process deviations and follows up to ensure corrective action has been taken
- Assists with conducting and developing standards and quality process training
- Perform compliance metrics and drive improvement on those metrics
- Oversees the development and implementation of processes, procedures, audits and corrective actions
- Work with external business partners and regulators to build capability and ensure compliance to quality standards
- Support Quality area on other processes required
- Education level required: Graduated Pharmacist, Chemical, Life Sciences, Engineer or any other related Health care Science with expertise in Quality Systems, Biology, Industrial Engineering, if the person has experience in Quality Systems, Chemical Engineering
- Years of Experience: At least, 4 years of experience in Quality Systems
- Required knowledge: Quality Systems (ISO, GMP), Quality audit, Quality & Compliance, Complaints, Supply Chain, Knowledge in GxP Regulations
- Required skills: Planning & Organization skills, Effective Communication skills written and verbal, management of Complexity, Prioritization of work to meet deadlines; can work under pressure, able to work on a timeline driven environment, Understands the importance of adhering to compliance, Flexible, open to change, proactive, Innovative
- Required Experience: Quality systems
- Language: Bilingual (English-Spanish) 80%
- Certifications: GMP or ISO auditor (optional)
- Travel percentage – Sporadic trips locally or internationally. 10%
- Location of the rol: Bogotá, edificio Calle 941700166264W
23
Supervisor, Quality Operations Resume Examples & Samples
- Trains QA Technicians on proper technique and procedures
- Schedules auditing assignments to staff
- Reviews daily in process audit paperwork
- Documents and investigates deviations, and non-conformances
- Assists in Annual Product Review/Annual Report Compliance
- Monitors the production processes and ensure consistency of procedures
- Oversees the verification of green release stickers issued to operations
- Oversees the automated inspection and AQL sampling of finished products
- Oversees the transfer of finished products to other Akorn facilities
- Reviews environmental monitoring of controlled areas
- Audits the maintenance of a clean sanitary environment
- Reviews and calculates theoretical yields for completed raw material records and cards
- Reviews mean kinetic temperature calculations
- Reviews System Alarm Messages
- Works with CAPA Coordinator or designee to ensure items are completed, documented and timely
- Assists with CAPA effectiveness checks
- Directly responsible for performance reviews, goal setting and personnel development plans for QA Technician I and II
- Recruiting, interviewing and hiring qualified employees to fill open positions
- Addressing complaints and resolving personnel problems within the department
- Maintaining confidentiality of information
- Bachelor’s Degree (BS or BA) from a 4 year college or university
- 5-10 years demonstrated excellence in in the pharmaceutical or related industry
24
Supervisor, Quality Resume Examples & Samples
- 2 + years quality control inspection experience
- Non-durable consumer goods industry and/or beauty product experience preferred
- 1 - 3 years supervisory experience
- Prior experience in manufacturing a plus