Job Description

*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.

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