Quality Assurance Job Description
Quality Assurance Duties & Responsibilities
To write an effective quality assurance job description, begin by listing detailed duties, responsibilities and expectations. We have included quality assurance job description templates that you can modify and use.
Sample responsibilities for this position include:
Quality Assurance Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Quality Assurance
List any licenses or certifications required by the position: QA, SQF, ISTQB, ISO, DSQR, GFSI, 9001, CFA, CPA, CCNA
Education for Quality Assurance
Typically a job would require a certain level of education.
Employers hiring for the quality assurance job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Collage Degree in Science, Medical, Computer, Engineering, Computer Science, Communication, Public Health, Health Care Administration, Education, Technical
Skills for Quality Assurance
Desired skills for quality assurance include:
Desired experience for quality assurance includes:
Quality Assurance Examples
Quality Assurance Job Description
- Responsible for reviewing and closing complaints in the TrackWise Complaint Database
- The review process will require the analyst to identify what was required to be included in the investigation and to determine what was completed to date
- The analyst will be required to write customer closure letters and will be required to interact with the Global Engineering and Service teams
- Managing complaints from initiation to closure, including identifying the type of investigations required
- Creating customer closure letters
- Working with the Global Service and Engineering teams to ensure accurate investigations are completed
- Monitor product quality through the performance of required visual and functional inspection
- Maintain a working knowledge of statistically based sampling plans and their applications
- May perform basic dimensional and/or visual inspection of assigned parts
- Use various measuring devices to ensure compliance with specifications
- Extensive domain knowledge of financial industry with expertise in product types and offerings
- An Associates Degree (AA) from an accredited university or college
- Bachelor’s degree in relevant field and 8 years of relevent experience
- Knowledge of FDA regulations (21 CFR 820 and 21 CFR 210/211) and ISO13485 is preferred
- Experience with MasterControl is preferred
- Responsible for data entry/management of nonconformance/discrepancy activities
Quality Assurance Job Description
- Perform periodic audits of manufacturing practices and local procedures
- Initiate and coordinate procedural changes in response to these audits
- Promote and actively participate in continuous improvement
- Review internal/external complaints in a timely manner
- This may include sample analysis, batch record review and historical trend review
- Use department databases to track and manage inspection workload and rejected products
- Writes and processes Non-Conforming Material Reports, as necessary, and manages inventory that is on hold for quality inspection
- Identify and report unusual quality conditions to Quality Department management employees for correction
- Initiate Incident Reports for non-conforming goods, out-of-specification processes, in process failures
- Perform and/or verify equipment calibration per established procedures and frequencies as directed
- Knowledge of GMP documentation and FDA desired
- Demonstrated attention to detail and accuracy required
- Basic software application skills (MS Office, Databases) required
- Minimum - 2 years of industry experience preferably in a GMP environment
- Bachelor's degree in science in order to understand the work
- Minimum 2 years’ experience in Inspection
Quality Assurance Job Description
- Lead investigations into product non-conformances and deficiencies
- Monitor quality metrics/ key performance indicators for contract sites and contribute to Business Review and Quality Management Review meetings
- Work with various internal departments as part of supplier selection, development and launch projects and other initiatives at third parties
- Assist in a variety of regulatory related support activities such as field alerts and recall execution support, as required
- As a member of the TPCQ Americas team, develop and implement Standard Operating Procedures (SOP's) to assure compliance with regulations, company corporate standards and contractual agreements
- Monitor consumer correspondence by selecting random contacts to determine proper handling according to written policies and procedures
- Create and quality observe data packages including consumer contacts received based upon specific scenarios and provide trend analysis
- Focus on monitoring based upon specific criteria and consumer dispute patterns
- Analyze the quality data to determine areas of improvement within policies and procedures
- Analyze the quality data focusing on critical quality areas to ensure CFPB exam readiness
- Minimum 2 years' experience working in a manufacturing setting
- Able to work second shift
- Previous experience in quality is required at least 1 year
- Must demonstrate ability to read and write in English in order to be qualified for the position
- Must demonstrate the ability to perform simple math such as addition, subtraction and multiplication based on company testing
- Candidate must have the ability to apply common sense understanding to carry out detailed written or verbal instructions
Quality Assurance Job Description
- Carrying out end-to-end operations deliverable for various portfolios, with the key focus on resource planning, resource hiring, training and quality assurance
- ATC testing on equipment prior to production run
- Analyze complex system related problems and recommend solutions
- Under the supervision of the PV QTC QC/QA Head the incumbent participates in activities ensuring suitability of the GPE quality system by performing quality assessment on the content of data/output and key Pharmacovigilance activities
- Maintains quality standards by approving incoming materials, in-process production, and finished products
- Experience working with Source Inspectors
- Be compliant and in good standing with all safety and security procedures
- Apply advanced techniques and procedures to assigned projects
- Work is performed under minimal supervision
- Receive shipments from different couriers and perform all related tasks
- Dependability and Punctual
- Reliable and good job tenure
- Bachelor's Degree in Chemistry, Pharmacy or related field from an accredited college or university, and 5-7 years pharmaceutical manufacturing experience, 3 of which must be in a quality capacity or an equivalent combination of education and experience
- Strong knowledge of drug regulations and guidelines
- Pharmaceutical processes, principles, practices and their application
- Analyzing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures or techniques for resolution
Quality Assurance Job Description
- Conduct destructive and non-testing to validate products performance to specifications
- Taking samples regularly
- Assist with Food Safety Training
- Maintaining current knowledge of SQF Code
- Comply with all food safety procedures, regulatory requirements and process efficiency
- Supports the Quality Lead for Deviations/CAPA as a Subject Matter Expert (SME) for the Baxalta Global Event Management Systems (GEMS, Current and Legacy systems)
- Supports GEMS process and closure of legacy Baxalta processes
- Supports GEMS and legacy Baxalta system metrics
- Responsible for supporting global event management processes and procedures (and others as necessary), by working with cross-functional working teams to develop and deploy CAPA processes that are standardized across and leverage best practices for business efficiency
- GEMS Expertise Council related to Legacy Baxalta GEMS that is comprised of Network Event Coaches from each of the Network Event Review Boards (Plasma, Recombinant, Small Molecule, BioLife, and Distribution)
- Demonstrated leadership in managing projects and/or product launches and ability to work independently
- Excellent negotiation, problem solving and prioritization skills
- Ability to work in a team, both in person and remotely and across various departments
- Role requires some travel (approximately 10%)
- Ability to assess and analyze data and create reports and PowerPoint presentations analyzing various data sets
- Detailed knowledge of credit reporting policies and procedures and functions a plus