Specialist Quality Assurance Job Description
Specialist quality assurance
provides quality review of documentation including batch records, C of As, deviations, CAPA, change controls, OOS investigations, stability data, etc.
Specialist Quality Assurance Duties & Responsibilities
To write an effective specialist quality assurance job description, begin by listing detailed duties, responsibilities and expectations. We have included specialist quality assurance job description templates that you can modify and use.
Sample responsibilities for this position include:
Performing routine manufacturing area inspections to ensure compliance with company procedures/policies, cGMP principles, and regulatory requirements (US and international)
Manage quality issues and investigations
Manage a limited number of deviation reviews
Reviewing and approving batch production records and associated supporting documentation
Performing equipment use log audits, communicating observations, and driving audit closures
Reviewing and approving new documents requests and/or document revisions
Performing manufacturing document issuance as needed
Generation of KPIs & Trend Reports on the Quality Systems
Supporting the generation of the Product Quality Review
Supporting Product Launches
Specialist Quality Assurance Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Specialist Quality Assurance
List any licenses or certifications required by the position: ASQ, QMS, ISO, SQF, AS9100, A&P, FAA, HACCP, CWI, II
Education for Specialist Quality Assurance
Typically a job would require a certain level of education.
Employers hiring for the specialist quality assurance job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Collage Degree in Education, Engineering, Science, Chemistry, Computer Science, Management, Technical, Biology, Business, Mathematics
Skills for Specialist Quality Assurance
Desired skills for specialist quality assurance include:
Principles
Oracle
Ability to learn technology quickly
Kronos
Call center business
Application of concepts
Technical capabilities to perform varied tasks
CAPA management
Deviations
Investigations
Desired experience for specialist quality assurance includes:
QA activities pertaining to Artwork
Visual quality assurance spot testing of video, audio, subtitle, and graphic files
Verification of XML documents for multiple vendors on a per order basis
Evaluate metadata and physical elements per unique vendor specifications
Complete QA reports detailing errors for package submissions
Demonstrable, working knowledge of XML creation, editing and troubleshooting
Specialist Quality Assurance Examples
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Specialist Quality Assurance Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of specialist quality assurance. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for specialist quality assurance
- Set and spearhead clear process improvement plans
- Collaborate with the Quality Assurance and Training Manager to develop an effective quality monitoring program
- Provide QA training to the Assessors, Monitors, and the QA staff in order that quality actions are incorporated into their daily practice
- Participate in the development of project goals and objectives, and monitoring achievement of those goals
- Examine data for outliers and research such cases
- Develop/complete reports that track and trend activities/outcomes
- Acts as an advisor to staff on all QA and Compliance issues related to the OPWDD Assessment project
- Participate in departmental administrative tasks related to handling and processing complaint and fair hearing requests
- Develop and implement corrective action plans
- Perform other duties as may be assigned by the QA and Training Manager
Qualifications for specialist quality assurance
- Must be client focused and customer service driven
- Computer experience - Microsoft Word and Excel
- Must have a valid driver's license, auto insurance and reliable, personal transportation
- Five (5) years of experience carrying out procedures to ensure that all products and services meet minimum organization standards and end-user requirements
- Experience testing hardware to ensure proper operation and freedom from defects
- Experience documenting and working to resolve all problems and reporting progress on problem resolution to management
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Specialist Quality Assurance Job Description
Job Description Example
Our company is growing rapidly and is hiring for a specialist quality assurance. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for specialist quality assurance
- QA support for implementation of Manufacturing Execution System (MES) and development of batch records
- Review and approve Validation protocols as required
- Coordinate new staff quality orientation and training ongoing quality training as needed
- Work as part of an automation team to understand requirements, documents, procedures, code
- Work with automation engineers at all stages to promote quality
- Produce quality reports
- Prioritize and leading of quality improvement activities/projects
- Work with automation engineers to perform root-cause analysis and preliminary problem diagnosis
- Assists in providing oversight of independent QA/QC inspection and testing provided by consultants and contractors
- Planning and co-coordination of day to day quality management activities and ensure that the entire management function of all areas takes place efficiently
Qualifications for specialist quality assurance
- Technological skills
- Junior Master / Bachelor’s degree in a scientific field, preferably in Life Sciences (bio
- Minimum 2–4 years’ experience in pharmaceutical GMP-regulated industries (Biotech preferred) and min 2 years in Quality Assurance/Compliance
- Related experience should be in GMP-regulated industries in Quality systems and Documentation
- Must have a working knowledge of FDA and ex-USA regulatory requirements pharmaceutical industry quality systems
- Minimum BS in Life Science with 7-9 years of relevant experience within the pharmaceutical or healthcare industry
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Specialist Quality Assurance Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of specialist quality assurance. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for specialist quality assurance
- Monitoring the work environment to make sure it remains safe, secure and well-maintained
- Evaluating progress against plans and adjusting as needed
- Establishing a worker reward/ recognition process
- Providing constant quality awareness and feedback
- Develop and improve processes in line with the regional BMS and local requirements
- Plan, manage and perform audits within the region according to the audit plan for the Region
- Follow-up & close out for internal / external audit findings (follow up and close corrective actions)
- Supplier quality management, reviews and audits (3rd party control)
- Quality support for distributor management
- Support local Business Units and cross-functional teams in ensuring compliance to processes and procedures
Qualifications for specialist quality assurance
- Working knowledge of MS-Office, including Excel, PowerPoint, Word, Outlook
- Active DHS EOD or ability to successfully complete DHS suitability
- Minimum BS degree in technical area and 3-4 years of experience
- Must have good word-processing skills and familiar with office software, MS Word, Excel, Power Point
- Ability to conduct audits within testing laboratories
- Specific vision requirements including reading of written documents
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Specialist Quality Assurance Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of specialist quality assurance. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for specialist quality assurance
- Provides a summary of all findings and documentation to management daily
- Participate in customer meetings related to product quality issues and concerns
- Interact with the materials group and external raw material suppliers on quality issues
- Conduct tool and gauge calibration activities for both internal and external calibration
- Through independent audit of product and procedures identify nonconformance and systemic failure, recommend corrective/preventive action, assure containment of at risk product and exercise stop work authority
- Assist in the training of personnel in company processes, Standard Operating Procedures, product specifications, customer requirements and lead Certified Quality Operator program
- Conduct receiving inspection activities verifying raw material compliance to specifications and engineering drawings
- Conduct in-process and final product inspection activities
- Conduct internal audits across the site in support of the ISO 9001 requirements
- Provide guidance and training to manufacturing and other functions in implementing good documentation practices
Qualifications for specialist quality assurance
- Seven (7) years of professional quality assurance/control experience on large/complex transportation systems
- Experience in laboratory, manufacturing, information/automation systems, or technical support, and interpretation and application of GMP Validation expectations
- Must have strong analytical skills in order to develop and recognize appropriate action plans and how they will impact operations and compliance
- Evaluate software and hardware requirements, and make decisions related to the system selection and support process
- Requires knowledge and experience in the Quality Assurance discipline and solves a range of straightforward problems
- Expresses views and ideas at the right time while actively encouraging team members to make suggestions and share ideas
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Specialist Quality Assurance Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of specialist quality assurance. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for specialist quality assurance
- Identifies improvement opportunities and acts as a change agent for departmental/enterprise initiatives within assigned area(s) of responsibility
- Performs and delivers on routine assignments with expertise, and proactively seeks cross training and or new initiatives
- Represents the interests of assigned area/team on basic projects assigned by management including technical, procedural and IT related
- Proactively develops analysis and metrics for assigned area(s), identifying areas for focus and improvement
- Provide coaching and quality feedback to individuals and their leaders
- Develop individualized plans for improvement when and where needed
- Conduct quality monitoring and deliver timely and helpful feedback to trainees
- Responsible for reading and interpreting documents to review work for quality
- Identify and drive improvements in procedures to increase clarity, efficiency, consistency or to document new processes
- Redirect self and team quickly to changes in direction or priorities
Qualifications for specialist quality assurance
- SAP/Trackwise system experience
- Understanding of Quality Management Systems for drugs, devices, biologics including risk management
- Energy, self-motivated, proactive and endurance to stay focused on the task at hand and thrives on the challenge
- Appropriate qualifications
- Knowledge of a European language or languages would be desirable
- Good understanding of Microsoft tools, knowledge of SharePoint (Hub)