QC Associate

QC Associate (Microbiology / Environmental Monitoring / GMP) - Onsite | Fremont, CA | 6-Month Contract Location: Fremont, CA (Onsite) Schedule: Monday - Friday | 8:00 AM - 5:00 PM Duration: 6-Month Contract (Potential Extension) Company: Sigma Inc. Job Overview Sigma Inc. is seeking a motivated QC Associate with experience in microbiology, environmental monitoring, and GMP laboratory environments. This role will support quality control testing of raw materials, bulk drug substances, and drug products in a multi-product pharmaceutical/biotech facility. This is an excellent opportunity for candidates with cleanroom experience, aseptic techniques, and LIMS knowledge to grow within a regulated QC environment. Key Responsibilities Perform microbiological testing and environmental monitoring (EM) in cleanroom environments Execute raw material sampling and compendial testing Conduct sample management, tracking, and documentation in LIMS systems Perform data entry, technical review, and quality review of test results Ensure compliance with GMP, SOPs, and quality standards Maintain lab equipment logs, documentation, and controlled records Coordinate sample shipment to external/contract labs Maintain cleanliness and organization of QC laboratories Support cross-functional teams (Sample Management, QC Labs, Raw Materials) Follow cleanroom gowning procedures and aseptic techniques • Required Qualifications Bachelor's Degree in a Scientific Discipline (Microbiology preferred) 1-3 years of GMP lab and/or cleanroom experience Hands-on experience with: Microbiology testing / Environmental Monitoring (EM) Aseptic techniques and cleanroom gowning Pipetting and lab techniques Familiarity with: LIMS (Laboratory Information Management Systems) GMP documentation and SOPs Strong attention to detail and data accuracy Ability to work independently and in a team environment Willingness to support weekend or flexible shifts as needed Preferred Qualifications Experience in pharmaceutical or biotech QC labs Knowledge of compendial methods (USP/EP) Experience with sample management and logistics in lab environments Physical & Work Environment Work in controlled lab and cleanroom environments Must follow strict gowning and aseptic procedures May require standing for extended periods and handling samples

Created: 2026-04-08