QC Analyst I

Location: Novato, CA.

12 month assignment

Pay Rate: $28/hr.

On behalf of our client a pharmaceutical leader specializing in the development of therapeutics for patients dealing with life threatening rare genetic diseases. We are seeking a QC Analyst I to perform biochemical, physical, and chemical analyses of test samples under cGMP conditions, ensuring data integrity and compliance with regulatory requirements. The successful candidate will play a key role in maintaining a high standard of quality control while supporting the laboratory's operational needs.

Key Responsibilities:

• Conduct biochemical, physical, and chemical analyses of test samples following cGMP guidelines, meeting specified timelines.
• Evaluate test results against established criteria and specifications.
• Independently perform mastered assays and develop expertise in a wide range of test methods.
• Train other analysts in areas of personal expertise.
• Maintain laboratory readiness for inspections and ensure supply inventory is adequately managed.
• Oversee routine laboratory functions such as glassware cleaning to meet operational requirements.
• Develop and maintain familiarity with regulatory requirements, including cGMP, 21CFR, USP, EP, and ICH guidelines.
• Collaborate with cross-functional teams to address quality control needs.
• Revise and update written procedures as needed, adhering to company policies and quality standards.

Education and Qualifications:

• B.S./B.A. in Biology, Biochemistry, Chemistry, or a related scientific field, with 2+ years of relevant laboratory experience.Strong ability to follow written instructions with minimal supervision.
• 1+ years of experience in a cGMP/GLP laboratory, with a focus on quality control.
• Proficiency in computer applications, including Windows, Microsoft Word, and Excel.
• Strong documentation skills and attention to detail.
• Ability to work independently and as part of a team.

Please submit a copy of your resume in PDF or Word Document to be considered.