Quality Control Analyst I, Raw Materials (Biotech)

TL;DR

Quality Control Analyst I, Raw Materials (Biotech): Inspecting and sampling incoming raw materials to ensure conformance to approved specifications with an accent on GMP compliance and accurate documentation. Focus on executing sampling protocols, managing nonconformance reports, and collaborating with supply chain and external laboratories.

Location: Onsite in Newark, CA

Salary: $33.00 – $37.00 per hour

Company

Clinical-stage biotechnology company pioneering allogeneic CAR T cell products for cancer and autoimmune diseases.

What you will do

• Inspect and sample raw materials against established specifications.
• Document all activities in a GMP environment, ensuring accuracy and completeness per cGMP.
• Initiate nonconformance reports for unacceptable materials and report issues to management.
• Contribute to the design of inspection, sampling, testing, and vendor qualification programs.
• Collaborate with internal QC, QA, and Supply Chain teams, as well as external contract labs.
• Support master data entry in SAP and LIMS systems.

Requirements

• B.S. in Chemistry, Biochemistry, Biology, or a related field.
• 2-4 years of experience in a GMP quality control environment.
• Experience with raw material sampling and inspection.
• Must be authorized to work in the U.S.
• Strong understanding of GMP requirements and QC systems.

Nice to have

• Experience in raw material compendial testing.
• Proficiency in using LIMS and/or SAP systems.

Culture & Benefits

• Annual performance bonus and equity.
• Comprehensive health insurance.
• Generous time off, including two annual company-wide holiday shutdowns.
• Collaborative environment working with talented specialists in cell therapy.