Senior Quality Control Analyst / Biologics

Mykelly; Emeryville (CA); In loco; USD 51.000 - 59.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

GMP/QC experience

HPLC/UPLC

Data integrity

IC H and USP guidance

Analytical troubleshooting

Documentation and records

Communication

Formazione

Bachelor’s degree in a scientific discipline

Master’s degree in a scientific discipline

Strumenti

Analytical methods development

Method validation/transfer

Descrizione del lavoro

Kelly® Science & Clinical is seeking a Senior Quality Control Analyst for a 4-6-month contract opportunity with one of our clients, a leading biologics CDMO in Emeryville, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology and medical device industries.

Workplace: Emeryville, CA.

Position Title: Senior Quality Control Analyst

Position Type: 4-6-month Contract

Pay rate: $37-43 hour

Transform the Future of Biomanufacturing

A biopharmaceutical contract development and manufacturing organization (CDMO) is seeking a hands‑on Senior QC Analyst to support analytical testing across raw materials, in‐process samples, product release, and stability programs.

This role is a strong fit for an experienced GMP analyst who enjoys solving technical problems, strengthening analytical methods, and helping a collaborative QC team deliver reliable, inspection‑ready results. You’ll work across QC and partner functions, contribute to programs from early development through commercial readiness, and provide technical guidance to junior analysts.

Responsibilities

• Perform GMP in-process, release, and stability testing using HPLC/UPLC, residual ELISA, and other qualified analytical methods.
• Execute testing in accordance with approved methods, protocols, and SOPs, maintaining complete and contemporaneous GMP records.
• Independently perform complex assays, troubleshoot method and instrument issues, and support laboratory investigations.
• Contribute to analytical development and nonclinical testing supporting IND-enabling, CMC, and BLA programs.
• Author and revise analytical methods, and support method development, qualification, validation, and transfer in alignment with applicable ICH guidance and internal quality standards.
• Document deviations and contribute to root‑cause investigations and CAPA implementation.
• Review GMP data packages and analytical validation documentation for accuracy, completeness, and compliance.
• Help maintain laboratory readiness by preparing reagents and reference standards, managing supplies, and following safe laboratory practices.
• Perform routine equipment maintenance, monitor calibration status, and coordinate service when needed.
• Train, mentor, and provide technical guidance to junior QC analysts.
• Support regulatory inspections, client audits, and other quality engagements.
• Identify opportunities to improve QC workflows, compliance, and analytical robustness.

Qualifications

• Bachelor’s degree in a scientific discipline and 3–5 years of relevant GMP/QC experience, or a master’s degree in a scientific discipline and 1–3 years of relevant experience.
• Hands‑on experience in a GMP‑regulated QC chemistry or analytical laboratory.
• Working knowledge of cGMP requirements, data integrity principles, and applicable ICH and USP analytical guidance.
• Experience with analytical method development, qualification, validation, and/or transfer.
• Ability to troubleshoot analytical assays and resolve instrument‑or‑related issues.
• Strong attention to detail and sound judgment in generating, documenting, and reviewing GMP data.
• Clear written and verbal communication skills, with the ability to collaborate across QC and partner functions.
• A practical, problem‑solving approach and the ability to contribute to investigations and effective corrective actions.
• Ability to work independently while contributing to a small, high‑performing team.
• Experience supporting client or regulatory audits is preferred.

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