Job Details

QC Specialist - Biotechnology

  2025-10-25     Astrix     Redwood City,CA  
Description:

Our client, a leading biotechnology manufacturer in the therapeutics space, is seeking a QC Specialist with strong LIMS expertise to drive analytical testing, ensure data integrity, and advance digital lab process improvements.

Title: QC Specialist - Biotechnology
Pay: $45-52/hr
Location: Redwood City, CA
Contract to hire


We are seeking a QC Specialist with strong LIMS expertise to support analytical testing, data integrity, and digital lab process improvements in a biotechnology environment. This role will ensure compliance with quality standards while collaborating with Quality, Manufacturing, and R&D teams to support product release, stability testing, and process improvements.

Key Responsibilities

  • Perform analytical and functional QC testing of raw materials, in-process, and final product batches
  • Manage and review data within LIMS to ensure accuracy and traceability
  • Author and revise SOPs, test methods, and QC documentation in compliance with cGMP / ISO standards
  • Support OOS investigations, deviations, and change control activities in collaboration with QA
  • Assist with equipment calibration, troubleshooting, and maintenance
  • Contribute to method qualifications, process validation, and audit readiness

Qualifications
  • Bachelor's degree in Biology, Chemistry, Biochemistry, or related field
  • 2-4+ years of QC experience in biotech, pharma, or biomanufacturing
  • Hands-on experience with LIMS and strong knowledge of GMP/GLP/ISO standards

Preferred
  • Experience with HPLC, ELISA, PCR, spectrophotometry, or enzymatic assays
  • Familiarity with ERP/ELN systems and digital documentation tools
  • Background in enzyme, protein, or biologics manufacturing

    INDBH


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