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.
