Senior QC Analyst (Contract) - Biologics GMP Testing

Mykelly; Emeryville (CA); On-site; USD 51,000 - 59,000; Full time

Job summary

Kelly® Science & Clinical is seeking a Senior Quality Control Analyst for a 4-6 month contract in Emeryville, CA. The role focuses on GMP‑compliant analytical testing across raw materials, in‑process samples, product release, and stability programs.

You will provide technical guidance to junior analysts, support method development and transfer, and collaborate across QC and partner functions to ensure inspection‑ready results. Prior GMP lab experience and strong communication are essential.

Qualifications

• Bachelor’s degree in a scientific discipline with 3–5 years GMP/QC experience or Master’s with 1–3 years experience.
• Hands‑on experience in a GMP‑regulated QC chemistry or analytical lab.
• Working knowledge of cGMP, data integrity, ICH and USP guidance.
• Experience with analytical method development, qualification, validation, and/or transfer.
• Ability to troubleshoot assays and instrument issues.
• Strong detail orientation and judgment in GMP data handling.
• Clear written/verbal communication across QC and partner functions.
• Independent yet collaborative in a small high‑performing team.
• Experience supporting client or regulatory audits is preferred.

Responsibilities

• Perform GMP in-process, release, and stability testing using HPLC/UPLC and other validated methods.
• Execute testing per approved methods and SOPs with complete GMP records.
• Independently perform complex assays and troubleshoot instrument issues.
• Contribute to analytical development and nonclinical testing for IND/CMC/BLA programs.
• Author and revise analytical methods; support method development, qualification, validation, transfer.
• Document deviations and assist in CAPA investigations.
• Review GMP data packages and validation documentation for accuracy and compliance.
• Maintain readiness by preparing reagents, standards, and supplies; follow safety practices.
• Coordinate instrument service and routine maintenance; track calibration status.
• Train and mentor junior QC analysts; support regulatory audits and client inspections.
• Identify opportunities to improve QC workflows and analytical robustness.

Skills

GMP/QC experience

HPLC/UPLC

Data integrity

IC H and USP guidance

Analytical troubleshooting

Documentation and records

Communication

Education

Bachelor’s degree in a scientific discipline

Master’s degree in a scientific discipline

Tools

Analytical methods development

Method validation/transfer

Job description

Kelly® Science & Clinical is seeking a Senior Quality Control Analyst for a 4-6 month contract in Emeryville, CA. The role focuses on GMP‑compliant analytical testing across raw materials, in‑process samples, product release, and stability programs.

You will provide technical guidance to junior analysts, support method development and transfer, and collaborate across QC and partner functions to ensure inspection‑ready results. Prior GMP lab experience and strong communication are essential.