Senior QC Specialist – Biopharma Analytics

Sigma Systems, Inc.; Fremont (CA); On-site; USD 75,000 - 110,000; Full time

Job summary

Sigma Inc is seeking a Sr. QC Associate to join our Fremont, CA site. The 1st shift runs Monday–Friday, 8:00 AM–5:00 PM.

You will contribute to QC across HPLC/CE, potency testing, residual impurities, and microbiology, handling bulk drug substances and drug products in a multi-product facility. Responsibilities include authoring test methods, specs, plans, reports, SOPs, and training other associates while maintaining compliance with cGMP and GDP standards.

Qualifications

• Six+ years of experience in a cGMP regulated environment with a High School Diploma.
• Four years of experience in a cGMP regulated environment with an Associate Degree.
• Two+ years of experience in a cGMP regulated industry with a Bachelor's degree in a science or engineering field.

Responsibilities

• Executes independently 3–5 analytical testing methods under supervision.
• Manages buffer preparation, TCU maintenance, and cleaning.
• Documents work according to cGMP and GDP standards.

Skills

Attention to detail

Data analysis

Written and verbal communication

Education

High School Diploma

Associate Degree

Bachelor’s Degree in science or engineering

Job description

Sigma Inc is seeking a Sr. QC Associate to join our Fremont, CA site. The 1st shift runs Monday–Friday, 8:00 AM–5:00 PM.

You will contribute to QC across HPLC/CE, potency testing, residual impurities, and microbiology, handling bulk drug substances and drug products in a multi-product facility. Responsibilities include authoring test methods, specs, plans, reports, SOPs, and training other associates while maintaining compliance with cGMP and GDP standards.