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- Review and approve discrepancy investigations including, but not limited to, deviations, calibration exceptions, out-of-specification (OOS) results, and out-of-limit (OOL) results; ensure discrepancy reports meet procedural and regulatory requirements, including requirements for root cause analysis and impact assessment.
- Review and approve CAPA records.
- Ensure accuracy of records and reports, including stability reports.
- Advise production on proper documentation requirements as needed.
- Review batch production records.
- Review of Manufacturing forms and paperwork in association with Batch Production Records.
- Maintain a state of inspection readiness.
- Maintain company quality and safety standards.
- Collaborate with Management to establish and meet targets and timelines.
- Independently manage competing priorities with limited instruction.
- Serve as a Quality representative on cross-functional and multi-site teams.
- Identify and recommend solutions to potential procedure, process, and system gaps.
- Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
- Represent Quality Assurance on multi-disciplinary project teams.
- Collaborate with departments to ensure that all review activities are executed efficiently per governing SOPs.
- Perform tasks as requested by Management to support Quality oversight activities.
- B.A. or B.S. degree (preferably in Life Science).
- 4+ years of Quality experience in the biopharmaceutical industry.
- Strong knowledge of cGMP regulations.
- Strong knowledge of root cause analysis processes and tools.
- Must be able to gown for a class 10,000 cleanroom environment.
- Ability to interpret Quality standards for implementation.
- Skills to independently evaluate situations and propose potential solutions.
- You have a "bring it on" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
- You have exceptional multitasking skills, unparalleled attention to detail, and unwavering commitment to Quality.
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Sr. Specialist, Quality Assurance - Tustin, United States - Avid Bioservices
Description
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.Your Role: The Quality Assurance Sr. Specialist is an individual contributor who solves a variety of issues following cGMP regulations and company standards.
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