Senior Quality Control Analyst, Biologics

Mykelly; Emeryville (CA); Presencial; USD 51 000 - 59 000; Tempo integral

Resumo da oferta

Kelly Science & Clinical is seeking a hands-on Senior Quality Control Analyst in Emeryville, CA for a 4-6 month contract to support analytical testing across raw materials, in-process samples, product release, and stability programs. The role requires GMP/QC experience, HPLC/UPLC and ELISA methods, data integrity, and collaboration across QC and partner functions.

The successful candidate will train junior analysts, support regulatory inspections, and drive continuous improvement while

Qualificações

• Bachelor’s in a scientific field with 3–5 years GMP/QC experience.
• Hands-on GMP-regulated QC chemistry or analytical lab experience.
• Knowledge of cGMP, data integrity, ICH and USP guidance.
• Experience with method development, qualification, validation, or transfer.
• Strong problem-solving, attention to detail, and documentation skills.
• Ability to work independently in a small, high-performing team.
• Experience supporting client or regulatory audits preferred.

Responsabilidades

• Perform GMP in-process, release, and stability testing using HPLC/UPLC and ELISA.
• Maintain GMP records and execute methods per SOPs.
• Troubleshoot assays and instruments; support investigations.
• Support analytical development, IND-enabling, CMC, BLA programs.
• Author/revise analytical methods; assist transfer and qualification.
• Document deviations; contribute to CAPA and root-cause analysis.
• Review GMP data packs and validation docs for accuracy.
• Prepare reagents and standards; manage lab supplies.
• Maintain equipment; coordinate service when needed.
• Mentor junior analysts; support regulatory inspections and audits.
• Identify QC workflow improvements.

Conhecimentos

GMP QC

HPLC/UPLC

ELISA

cGMP

Data integrity

ICH guidelines

USP guidance

Method development

CAPA

Audit support

Formação académica

Bachelor's degree in science

Master's degree in science

Ferramentas

HPLC/UPLC systems

LIMS

Instrument calibration

Descrição da oferta de emprego

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.

What you’ll do

• 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.

What you’ll bring

• 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.