Sr. QC Associate

Senior QC Associate – Biopharmaceuticals | Fremont, CA | 12-Month Contract

Sigma Inc. is hiring a Senior Quality Control (QC) Associate in Fremont, CA!

Are you an experienced Quality Control professional with a background in biopharmaceutical manufacturing, analytical testing, and cGMP compliance? Sigma Inc. is seeking a detail-oriented Senior QC Associate to support laboratory testing, analytical data review, quality documentation, and continuous improvement within a regulated biopharmaceutical manufacturing environment.

This is an excellent opportunity for experienced QC professionals who can independently execute analytical methods, interpret scientific data, maintain compliance documentation, and support laboratory quality and training activities.

Job Details

• Job ID: 37757692

• Job Title: Senior QC Associate

• Location: Fremont, CA

• Contract Duration: 12 Months

• Work Arrangement: On-site

• Shift: 1st Shift

• Schedule: Monday–Friday, 8:00 AM–5:00 PM

Key Responsibilities

• Independently perform and coordinate analytical testing of bulk drug substances, drug products, and raw materials.

• Execute 3–5 analytical testing methods across different scientific principles, according to established procedures and training qualifications.

• Support assigned QC laboratory functions, including HPLC, capillary electrophoresis (CE), potency and binding assays, residual impurities, physicochemical testing, microbiology, environmental monitoring, raw materials, cleaning validation, or packaging testing.

• Perform laboratory activities such as buffer preparation, TCU maintenance, and cleaning.

• Review, analyze, and interpret analytical data to identify discrepancies, trends, and out-of-trend results.

• Prepare and maintain test methods, specifications, plans, reports, forms, and Standard Operating Procedures (SOPs).

• Document laboratory activities accurately in accordance with current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).

• Identify, document, and escalate deviations, abnormalities, and potential compliance issues.

• Support investigations, root cause analysis, and corrective and preventive actions as applicable.

• Maintain laboratory organization, cleanliness, and efficiency in accordance with 5S standards.

• Identify opportunities to improve laboratory processes and compliance activities.

• Train and mentor QC associates and technicians after obtaining the required trainer qualification.

• Collaborate with cross-functional teams to resolve technical issues and maintain quality standards.

• Follow laboratory safety procedures and report unsafe conditions or practices.

Required Qualifications

Candidates must meet one of the following education and experience combinations:

• High school diploma or equivalent with at least 6 years of experience in a cGMP-regulated industry.

• Associate degree with at least 4 years of experience in a cGMP-regulated industry.

• Bachelor's degree in a science- or engineering-related field with at least 2 years of experience in a cGMP-regulated industry.

Additional qualifications include:

• Experience performing analytical testing in a regulated manufacturing or laboratory environment.

• Understanding of analytical chemistry and testing principles applicable to biopharmaceutical products.

• Ability to independently perform multiple analytical methodologies with minimal supervision.

• Experience reviewing, interpreting, and trending scientific or analytical data.

• Knowledge of SOPs, test methods, cGMP, and cGDP documentation practices.

• Strong attention to detail and a quality-focused, right-first-time mindset.

• Strong written and verbal communication skills.

• Proficiency with computer-based laboratory or quality systems.

• Ability to collaborate effectively and troubleshoot moderately complex testing issues.

Preferred Qualifications

• Previous Quality Control experience in biopharmaceutical manufacturing.

• Experience with HPLC, CE, bioassays, binding assays, residual impurities, physicochemical testing, microbiology, environmental monitoring, or related analytical techniques.

• Experience authoring QC procedures, test methods, specifications, and compliance documentation.

• Experience with laboratory investigations, root cause analysis, and process improvement.

• Experience training other laboratory associates and technicians.

• Familiarity with process control systems and laboratory data trending.