Quality Systems/QA Frontline (Overnight)

Location: Novato, CA.

12 month assignment

Pay Rate: $40/hr.

Schedule:

Alternate Wednesdays, Thursday to Saturday: 6:00 PM - 7:00 AM

Alternate Wednesdays, Sunday to Tuesday: 6:00 PM - 7:00 AM

On behalf of our client a leading pharmaceutical company specializing in the development of therapeutics for patients dealing with life threatening rare genetic diseases. We are seeking for a Quality Systems associate to provide quality assurance oversight for our manufacturing operations during overnight shifts. This role is essential in ensuring that all manufacturing processes comply with cGMP standards and company procedures.

Key Responsibilities :

• Provide on-the-floor QA oversight and support to manufacturing operations.
• Review executed batch records and associated documents to ensure compliance with approved procedures and cGMP expectations.
• Respond to quality-related incidents or non-conformances on the floor and gather necessary documentation for real-time investigations.
• Act as a QA representative in support of deviations, including active participation in Root Cause Analysis (RCA).
• Offer cGMP and compliance guidance to Manufacturing and Novato Technical Services (NTS) personnel.
• Provide QA support, including authoring, review, and approval of documents within Quality Management Systems, following company policies.
• Conduct area walkthroughs to ensure adherence to QA standards.
• Perform additional duties and projects as assigned by management.

Skills & Qualifications :

• BS/BA in a scientific discipline or related field.
• 3+ years of experience in a biologics manufacturing environment.
• Experience with batch record execution or review.
• Previous experience in investigations, change control, and other Quality Management Systems (QMS).
• Strong understanding of current Good Manufacturing Practices (cGMP).
• Experience in Manufacturing and Manufacturing Sciences is preferred.