QC Associate

37281109 QC Associate - Fremont, CA (2nd Shift) | 6-Month Contract

Sigma Inc. is hiring a QC Associate for a leading biotech/pharmaceutical manufacturing client in Fremont, CA . This is an exciting opportunity for candidates with GMP laboratory experience, strong analytical testing skills, and a background in biology or life sciences to work in a fast-paced, regulated manufacturing environment.

This role supports Quality Control In-Process Testing (IPC) activities for bulk drug substances and intermediates within a multi-product facility.

Job Title

QC Associate - In-Process Testing (IPC)

Location

Fremont, California

Job Type

Contract - 6 Months

Shift Schedule

Training Period (Approx. First 3 Months)

• Monday-Friday
• 1st Shift

Post-Training Schedule

• Wednesday: 12:00 PM - 9:00 PM
• Thursday-Sunday: 12:00 PM - 11:00 PM
• 2nd Shift

Key Responsibilities

• Perform routine and non-routine QC testing of bulk drug substances and intermediates
• Execute laboratory testing independently following training and SOPs
• Conduct analytical testing including:
  • HPLC titer
  • UV-Vis absorbance
  • Endotoxin testing
  • pH testing
  • Osmolality
  • Total Organic Carbon (TOC)
  • Conductivity
  • Sample aliquotation
• Maintain laboratory inventory and consumables
• Properly dispose of expired reagents and laboratory materials
• Identify, document, and report equipment or process anomalies
• Deliver accurate analytical results within established timelines
• Maintain cGMP and cGDP compliant documentation
• Report deviations, abnormalities, and out-of-specification results promptly
• Follow all safety, regulatory, and quality procedures
• Maintain laboratory cleanliness and 5S standards
• Ensure training compliance and documentation accuracy

Required Qualifications

• Bachelor's degree in Biology, Life Sciences, or related scientific field
• 3-5 years of industry experience
• GMP laboratory experience preferred
• Strong attention to detail and documentation practices
• Ability to work independently and in a team environment
• Strong written and verbal communication skills

Preferred Technical Skills

• HPLC (titer)
• Aseptic technique
• Osmolality testing
• Total Organic Carbon (TOC)
• Conductivity testing
• UV-Vis analysis
• Endotoxin testing
• cGMP/cGDP documentation

Preferred Candidate Profile

We are seeking professionals who demonstrate:

• Strong analytical and troubleshooting skills
• High attention to detail
• Ability to work in regulated laboratory environments
• Excellent organizational and time-management abilities
• Commitment to safety and quality standards
• Ability to collaborate cross-functionally in manufacturing and QC environments