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Senior Quality Assurance Associate Investigations
2 months ago
Ajinomoto Bio-Pharma Services is seeking a Quality Assurance Associate Investigations to join our team.
About the RoleThis is a challenging and rewarding role that requires a strong understanding of quality assurance principles and practices. As a Quality Assurance Associate Investigations, you will be responsible for ensuring that our manufacturing areas are maintained in strict compliance with regulatory requirements.
Key Responsibilities- Independently review and approve production batch records and associated data for product release and determine if records are within range of cGMP regulations and good documentation practices.
- Identify, investigate, resolve, and prevent compliance/deviance issues by real-time review of batch records and walk-through of the manufacturing areas.
- Perform quality operations within multiple manufacturing departments.
- Participate in multiple process improvement projects.
- Develop, revise, review, and approve controlled documents including standard operating procedures (SOPs), Master Batch Records, analytical methods, protocols, and tech transfer forms.
- Review and approve executed technical documentation in support of the manufacturing and testing of Drug Substance and Drug Product.
- Represent QA for high-profile clients.
- Provide quality oversight of quality reports including deviations, corrective and preventive actions (CAPAs), and risk management plan (RMP).
- Provide quality support to clients by attending meetings as needed, addressing quality issues that arise, and advising clients on compliant solutions.
- Support the Facility/Equipment/Process Change Control System including developing recommendations for change tasks, managing timelines, and performing follow-ups to evaluate the effectiveness of changes.
- Ensure completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.
- Regular and reliable attendance on a full-time basis.
- High school diploma or equivalent required. Bachelor's degree preferred in a Life Sciences discipline or equivalent relevant experience required.
- Minimum of four to six (4-6) years of experience in documentation, QA, Manufacturing, technical quality, validation, or equivalent.
- Working knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices and data integrity.
- Knowledge of Fill Finish and Biologics production environments preferred.
- Familiarity working with electronic batch records.
- Detail-oriented and strong interpersonal and verbal communication skills.
Ajinomoto Bio-Pharma Services offers a competitive salary and benefits package, including health benefits, annual performance bonus, generous paid time off, paid parental leave, matching 401(k) contributions (immediate vesting), tuition reimbursement, employee discount program, and much more.
We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and detail-oriented individual who is passionate about quality assurance, we encourage you to apply for this exciting opportunity.
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