Senior QC Analyst - Biotech Contract (Emeryville)

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

Benefits offered by this job

Health insurance

Transit spending account

Paid holidays

Job summary

Kelly Science & Clinical is seeking a Senior Quality Control Analyst in Emeryville, CA for a 4‑6 month contract. The role focuses on GMP testing of materials and products using HPLC/UPLC and ELISA, ensuring cGMP compliance and continuous process improvements.

You will support method development, validation, investigations, and audits while mentoring junior analysts and maintaining meticulous GMP records throughout the testing lifecycle.

Qualifications

• Bachelor’s degree in a scientific discipline with 3–5 years GMP/QC experience or Master’s with 1–3 years.
• Hands‑on experience in a GMP‑regulated QC chemistry or analytical laboratory.
• Working knowledge of cGMP, data integrity, ICH and USP guidance.

Responsibilities

• Perform GMP in‑process, release, and stability testing using HPLC/UPLC, residual ELISA, and other qualified methods.
• Maintain complete GMP records and follow SOPs and approved protocols.
• Troubleshoot assays and instrument issues; support laboratory investigations.
• Contribute to analytical development and IND‑enabling programs.
• Assist in method development, qualification, validation, and transfer per ICH guidance.
• Document deviations and contribute to CAPA investigations.
• Review GMP data packages for accuracy and compliance.
• Prepare reagents and reference standards and ensure laboratory readiness.
• Train and mentor junior QC analysts; support regulatory inspections.

Skills

GMP/QC experience

Analytical testing

Laboratory troubleshooting

Mentoring junior staff

Education

Bachelor’s degree in a scientific discipline

Master’s degree in a scientific discipline

Tools

HPLC/UPLC

ELISA

Analytical instruments maintenance

Job description

Kelly Science & Clinical is seeking a Senior Quality Control Analyst in Emeryville, CA for a 4‑6 month contract. The role focuses on GMP testing of materials and products using HPLC/UPLC and ELISA, ensuring cGMP compliance and continuous process improvements.

You will support method development, validation, investigations, and audits while mentoring junior analysts and maintaining meticulous GMP records throughout the testing lifecycle.