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QC Specialist - Biotechnology

QC Specialist - Biotechnology

Astrix IncRedwood City, CA, United States
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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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