Associate, QA Frontline
QA Specialist – Biopharmaceuticals Manufacturing Operations
Location: Novato, CA (On-site)
Schedule: Alternating Saturdays off, Sunday – Tuesday | 6:00 PM – 7:00 AM (overnight)
Duration: 12-Month Assignment – High potential to extend or Convert to FTE
Pay: $40/hour
We are seeking a detail-oriented and proactive QA Operations Specialist to provide on-the-floor quality oversight and support for biopharmaceuticals manufacturing operations. This role ensures compliance with cGMP standards and plays a key part in maintaining product quality and regulatory adherence.
Key Responsibilities:
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Provide real-time QA oversight to manufacturing operations, ensuring adherence to cGMP requirements.
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Review executed batch records and associated documentation to confirm compliance with approved procedures.
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Respond to quality-related incidents on the floor, securing necessary documentation for investigations.
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Support and actively participate in Root Cause Analysis (RCA) for deviations and non-conformances.
Qualifications & Requirements:
Education: B.S. in a scientific discipline or equivalent work experience.
- Prior experience in batch record execution or review.
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Familiarity with investigation processes, change control, and other QMS functions.
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Strong working knowledge of cGMPs and regulatory compliance.
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Excellent communication skills with a strong analytical and problem-solving mindset.
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Preferred: Experience in Manufacturing or Manufacturing Sciences.
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