QC Associate

QC Associate I – Quality Control Laboratory

Fremont, CA | Onsite | 6-Month Contract | 1st Shift (Monday–Friday, 9:00 AM–5:00 PM)

Sigma Inc. is hiring a QC Associate for our client in Fremont, CA. This is an excellent opportunity for a Quality Control professional with GMP laboratory experience who is passionate about ensuring product quality, regulatory compliance, and continuous process improvement in a fast-paced biopharmaceutical manufacturing environment.

If you have experience with Quality Control testing, investigations, cGMP documentation, laboratory instrumentation, and quality systems, we'd love to hear from you!

• Perform routine and non-routine Quality Control testing for bulk drug substances and drug products.
• Review, interpret, trend, and verify analytical test results while ensuring accuracy and timely completion.
• Support investigations involving deviations, out-of-specification (OOS) results, CAPAs, and change controls.
• Assist with quality risk assessments, laboratory equipment qualification, validation, and implementation of new technologies.
• Participate in cross-functional projects supporting Quality Control compliance initiatives.
• Maintain accurate laboratory documentation in accordance with cGMP and cGDP requirements.
• Support internal and external audits, inspections, and regulatory compliance activities.
• Perform laboratory techniques including:
  • Biochemistry testing
  • Drug product/device testing
  • UV-Visible Spectroscopy
  • Gel Electrophoresis
  • Osmolality Testing
  • Microbiology
• Review analytical data accurately and within required timelines.
• Identify and report deviations, abnormalities, and quality issues promptly.
• Follow all laboratory safety procedures and escalate unsafe conditions when necessary.
• Maintain required training records and assist in training laboratory personnel after qualification.
• Represent Quality Control on cross-functional root cause analysis teams.

• Bachelor's Degree in Biology, Life Sciences, Biochemistry, Microbiology, or a related scientific discipline.
• 3–5 years of Quality Control experience within a GMP-regulated pharmaceutical, biotechnology, or biologics environment.
• Strong understanding of:
  • cGMP
  • cGDP
  • OOS Investigations
  • CAPA
  • Deviations
  • Change Control
• Excellent analytical, organizational, and documentation skills.
• Strong written and verbal communication skills.
• Ability to work independently while collaborating with cross-functional teams.
• Strong attention to detail and commitment to quality.

Experience with:

• LIMS
• Veeva
• Go Track
• Laboratory equipment qualification and validation
• Quality risk assessments
• FDA-regulated manufacturing environments

• Location: Fremont, CA
• Duration: 6-Month Contract
• Shift: Monday – Friday
• Hours: 9:00 AM – 5:00 PM
• Work Setting: Onsite