QC Associate – GMP Laboratory | HPLC | Biotechnology | Fremont, CA | 6-Month Contract

Job ID: 37506390
Location: Fremont, CA (Onsite)
Job Type: 6-Month Contract
Shift: Monday–Friday | 8:00 AM – 5:00 PM

Join Our Team

Sigma Inc. is seeking a detail-oriented Quality Control (QC) Associate to join our client's Quality Control In-Process Testing (IPC) team in Fremont, CA. This role is ideal for candidates with laboratory experience in a GMP-regulated biotechnology, pharmaceutical, or life sciences environment.

The successful candidate will perform in-process testing of bulk drug substances and intermediates, conduct a variety of analytical laboratory assays, maintain compliance with cGMP and cGDP requirements, and ensure accurate, high-quality testing results in a fast-paced manufacturing environment.

Key Responsibilities

• Perform routine and non-routine Quality Control In-Process (IPC) testing of bulk drug substances and manufacturing intermediates.
• Independently perform laboratory testing following approved procedures and training.
• Conduct analytical testing including:
  • HPLC (Titer)
  • UV-Visible Spectroscopy (UV-Vis)
  • Endotoxin Testing
  • pH Testing
  • Osmolality
  • Total Organic Carbon (TOC)
  • Conductivity
  • Sample Aliquotation
• Generate accurate, reliable, and timely analytical data while maintaining Right First Time quality standards.
• Document laboratory activities in compliance with cGMP, cGDP, and company quality procedures.
• Maintain laboratory supplies, reagents, consumables, and inventory.
• Dispose of expired chemicals and reagents according to laboratory procedures.
• Identify, document, and report equipment issues, process abnormalities, deviations, and out-of-specification (OOS) results.
• Follow all laboratory safety procedures and immediately report unsafe conditions.
• Maintain laboratory organization and cleanliness using 5S principles.
• Ensure all required training remains current and compliant with company and regulatory requirements.
• Collaborate with Quality, Manufacturing, and cross-functional teams to support production schedules and quality objectives.

Required Qualifications

• Bachelor's degree in Biology, Life Sciences, or a related scientific discipline.
• 3–5 years of laboratory experience in biotechnology, pharmaceutical, or life sciences.
• GMP experience preferred.
• Experience performing analytical laboratory testing.
• Strong documentation skills with experience following regulated laboratory procedures.
• Excellent attention to detail and commitment to data accuracy.
• Strong written and verbal communication skills.
• Ability to work independently while also contributing effectively within a team environment.

Preferred Technical Skills

Experience with one or more of the following laboratory techniques:

• HPLC (Titer)
• UV-Visible Spectroscopy (UV-Vis)
• Endotoxin Testing
• Aseptic Technique
• Osmolality
• Total Organic Carbon (TOC)
• Conductivity
• pH Testing
• Sample Aliquotation
• Laboratory Documentation
• cGMP
• cGDP
• 5S Laboratory Practices

Preferred Qualifications

• Experience supporting Quality Control In-Process (IPC) laboratories.
• Experience testing bulk drug substances or biopharmaceutical intermediates.
• Biotechnology or pharmaceutical manufacturing experience.
• Knowledge of FDA-regulated laboratory environments and quality systems.