Senior Quality Assurance Associate
1 day ago
Ajinomoto Bio-Pharma Services is seeking a highly skilled Senior Quality Assurance Associate - Investigations to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the highest standards of quality and compliance in our manufacturing processes.
Key Responsibilities- Quality Compliance: Independently review and approve production batch records and associated data to ensure compliance with cGMP regulations and good documentation practices.
- Investigations: Identify, investigate, resolve, and prevent compliance/deviance issues by real-time review of batch records and walk-through of the manufacturing areas.
- Process Improvements: Drive process improvements and enhancements, and participate in multiple process improvement projects.
- Document Control: Develop, revise, review, and approve controlled documents, including standard operating procedures (SOPs), Master Batch Records, analytical methods, protocols, and tech transfer forms.
- Quality Oversight: Provide quality oversight of quality reports, including deviations, corrective and preventive actions (CAPAs), and risk management plans (RMP).
- Client Support: Provide quality support to clients by attending meetings, addressing quality issues, and advising clients on compliant solutions.
- Facility/Equipment/Process Change Control: 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.
- Documentation and Record-Keeping: Ensure completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.
- Education: High school diploma or equivalent required; Bachelor's degree preferred in a Life Sciences discipline or equivalent relevant experience.
- Experience: Minimum of four to six (4-6) years of experience in documentation, QA, Manufacturing, technical quality, validation, or equivalent.
- Knowledge and Skills: 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.
Ajinomoto Bio-Pharma Services offers a competitive salary range of $39.51 per hour for candidates working in California. The final salary offered will be dependent on several factors, including experience, education, and industry background.
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