Sunday-Tuesday 6pm-7am; alt. Saturday
Job Summary:
We are seeking a dedicated and detail-oriented Quality Assurance Specialist to provide on-the-floor QA oversight for manufacturing operations. This role ensures compliance with cGMP standards and supports real-time quality investigations. The ideal candidate will have strong analytical skills, a working knowledge of Quality Management Systems (QMS), and flexibility to work primarily during night and weekend shifts, with occasional variation based on operational needs.
Responsibilities:
- Provide real-time QA support and oversight to manufacturing operations, ensuring alignment with cGMP and internal procedures.
- Review executed batch records and associated documentation for completeness, accuracy, and compliance.
- Respond to quality incidents and non-conformances on the floor, securing necessary documentation for timely investigations.
- Represent QA in deviation investigations and participate in Root Cause Analysis (RCA) to drive resolution.
- Offer cGMP and compliance guidance to Manufacturing and Novato Technical Services (NTS) personnel.
- Author, review, and approve quality documents within the Quality Management System (QMS) in line with company policies.
- Conduct area walkthroughs to ensure facility and procedural compliance.
- Support additional projects and responsibilities as assigned by management.
Qualifications:
- B.S. in a scientific discipline or equivalent work experience.
- Prior experience with batch record execution or review required.
- Familiarity with quality systems including investigations and change control.
- Working knowledge of current Good Manufacturing Practices (cGMPs).
- Background in Manufacturing or Manufacturing Sciences is preferred.
- Willingness to work primarily night and weekend shifts, with flexibility for schedule adjustments.