What are the responsibilities and job description for the QA Operations Specialist position at Tucker Parker Smith Group (TPS Group)?
QA Specialist – Biopharmaceuticals Manufacturing Operations
Location: Novato, CA (On-site)
Schedule: Alternating Wed, Thurs-Sat | 6:00 AM – 7:00 PM
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:
- Provide real-time QA oversight to manufacturing operations, ensuring adherence to cGMP requirements.
- Review executed batch records and associated documentation to confirm compliance with approved procedures.
- Respond to quality-related incidents on the floor, securing necessary documentation for investigations.
- Support and actively participate in Root Cause Analysis (RCA) for deviations and non-conformances.
- Offer cGMP guidance to Manufacturing and Novato Technical Services (NTS) personnel.
Qualifications & Requirements:
Education: B.S. in a scientific discipline or equivalent work experience.
- Prior experience in batch record execution or review.
- Familiarity with investigation processes, change control, and other QMS functions.
- Strong working knowledge of cGMPs and regulatory compliance.
- Excellent communication skills with a strong analytical and problem-solving mindset.
- Preferred: Experience in Manufacturing or Manufacturing Sciences.
Salary : $40
