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Senior Quality Assurance Associate Investigations
2 months ago
Ajinomoto Bio-Pharma Services is seeking a Senior QA Associate Investigations to join our team. As a Quality Subject Matter Expert, you will ensure manufacturing areas are maintained in strict compliance. You will independently review and approve lot files, assess regulatory and quality risks in manufacturing activities and processes, and investigate, troubleshoot, and rectify issues as a result of QA analysis.
Responsibilities:- Identify, investigate, resolve, and prevent compliance/deviance issues by real-time review of batch records and walk-through of the manufacturing areas
- Independently reviews and approves production batch records and associated data for product release and determines if records are within range of cGMP regulations and good documentation practices
- Independently performs quality operations within multiple manufacturing departments
- Participates 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
- Reviews and approves executed technical documentation in support of the manufacturing and testing of Drug Substance and Drug Product
- Represents QA for high profile clients
- Provides quality oversight of quality reports including deviations, corrective and preventive actions (CAPAs) and risk management plan (RMP)
- Provides quality support to clients by attending meetings as needed, addressing quality issues that arise, and advising clients on compliant solutions
- Supports 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
- Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems
- Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices
- Embodies Aji Bio-Pharma's cultural values and aligns daily actions with department goals and company culture
- 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 is an Equal Opportunity Employer and welcomes applications from diverse candidates. We offer a competitive salary and benefits package, including health benefits, annual performance bonus, generous paid time off, paid parental leave, matching 401k contributions (immediate vesting), tuition reimbursement, employee discount program and much more.
Apply now by visiting our website and clicking on the "Careers" section. Please be sure to note where you saw our ad posting.
New hires will be asked to complete a background check and drug screen as a condition of employment. For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: FCIHO
We are an EOE dedicated to a diverse work force and Drug Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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