Pharmaceutical Quality Assurance Specialist

Location: Novato, CA (on-site)

Pay: $30-$39/hour

Shift: Alternate Sat, Sun - Tues 6pm - 7am

12-Month Assignment

Join a dynamic and innovative pharmaceutical team! Our client, a leader in the industry, is seeking a Quality Assurance Specialist providing on-the-floor QA oversight and support for manufacturing operations. Key duties include reviewing executed batch records for compliance with approved procedures and cGMP requirements, responding to quality-related incidents, and assisting with real-time investigations. Additional duties include performing area walkthroughs and managing various projects. The ideal candidate will have experience with batch record review, investigations, and change control, as well as strong problem-solving and communication skills.

Responsibilities:

• Review executed batch records for compliance with approved procedures and cGMP standards.
• Respond to quality-related incidents and support real-time investigations.
• Participate in Root Cause Analysis (RCA) for deviations and non-conformances.
• Provide cGMP and compliance guidance to Manufacturing and Technical Services staff.
• Author, review, and approve documents within Quality Management Systems (QMS).
• Conduct area walkthroughs to ensure compliance with quality standards.
• Support ongoing quality improvement projects and initiatives as assigned.
• Collaborate with various teams to resolve quality issues and improve processes.

Preferred Qualifications:

• Bachelor’s degree in a scientific discipline or equivalent work experience.
• Experience in investigations, change control, and other Quality Management Systems (QMS).
• In-depth knowledge of cGMPs.
• Proven ability to analyze problems and develop effective solutions.
• Experience in manufacturing or Manufacturing Sciences.
• Ability to collaborate effectively across cross-functional teams.