Senior QC Analyst, Biologics (Contract) – Emeryville

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

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

GMP QC

HPLC/UPLC

ELISA

cGMP

Data integrity

ICH guidelines

USP guidance

Method development

CAPA

Audit support

Education

Bachelor's degree in science

Master's degree in science

Tools

HPLC/UPLC systems

LIMS

Instrument calibration

Job description

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