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 method-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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