Quality Control Analyst – GMP Biotech & Peptide Programs

Yowei Therapeutics; Milpitas (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

PTO 10 days

Company-paid holidays

Transportation/carpool reimbursement

Job summary

Yowei Therapeutics is seeking a Quality Control Analyst to perform and review analytical testing supporting raw materials, in-process, release, and stability testing in a GMP-lab setting in Milpitas, CA. The role emphasizes data integrity, method troubleshooting, and collaboration with cross-functional teams.

The candidate will lead investigations, support CAPAs, and help maintain compliance with regulated laboratory practices, documenting results and preparing training materials.

Qualifications

• 5–7 years of QC analytical experience in GMP-regulated labs.
• Strong knowledge of cGMP, GDP, data integrity, OOS/OOT, deviations, CAPA, and controlled-document practices.
• Hands-on experience with chromatographic and analytical instrumentation, data systems, and method troubleshooting.

Responsibilities

• Perform and document routine and complex analytical testing per approved methods, specifications, SOPs, protocols, and schedules.
• Review raw data, calculations, chromatograms, audit trails, worksheets, and results for accuracy and completeness.
• Support or lead method transfer, verification, validation, troubleshooting, and lifecycle improvements for assigned methods.

Skills

QC analytical experience

cGMP knowledge

Data integrity

Documentation

Cross-functional communication

Education

Bachelor's degree in chemistry/biochemistry/pharmaceutical science

Tools

Chromatography instrumentation

Data systems

Job description

Yowei Therapeutics is seeking a Quality Control Analyst to perform and review analytical testing supporting raw materials, in-process, release, and stability testing in a GMP-lab setting in Milpitas, CA. The role emphasizes data integrity, method troubleshooting, and collaboration with cross-functional teams.

The candidate will lead investigations, support CAPAs, and help maintain compliance with regulated laboratory practices, documenting results and preparing training materials.