Senior QC Associate – Biopharma Analytics & Compliance

Sigma Systems, Inc.; Fremont (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Sigma Systems, Inc. in Fremont, CA is seeking a Sr. QC Associate to support analytical testing across multiple platforms in a fast‑paced biopharma environment.

You will perform and coordinate testing for HPLC/CE, bioassay, residual impurities, and related QC activities in a multi‑product facility. This role requires strong attention to detail, cGMP compliance, and the ability to train others. You will document work, review data for trends, and collaborate with cross‑functional teams to ensure

Qualifications

• Six or more years in a cGMP regulated environment with QC focus.
• Experience with analytical methods in biopharmaceuticals.
• Ability to train and mentor junior staff.
• Strong written and verbal communication.

Responsibilities

• Execute and coordinate analytical testing across multiple platforms.
• Maintain and improve lab processes and compliance.
• Train other associates on methods and compliance.
• Document work per cGMP and GDP standards.
• Review data, identify trends, and report deviations.

Skills

Attention to detail

cGMP knowledge

Analytical testing

Data review & interpretation

Documentation & SOPs

Team training

Education

Bachelor's degree in science or engineering

Associate degree in science

Tools

HPLC

System validation

Laboratory information systems

Job description

Sigma Systems, Inc. in Fremont, CA is seeking a Sr. QC Associate to support analytical testing across multiple platforms in a fast‑paced biopharma environment.

You will perform and coordinate testing for HPLC/CE, bioassay, residual impurities, and related QC activities in a multi‑product facility. This role requires strong attention to detail, cGMP compliance, and the ability to train others. You will document work, review data for trends, and collaborate with cross‑functional teams to ensure