QC Specialist

5 days ago

Redwood City, California, United States Astrix Full time $80,000 - $120,000 per year

Our client, a leading Biotechnology company, located in the San Mateo County area is looking for a talented QC Specialist (LIMS) to join their team
Job Title:
QC Specialist

Location:
San Mateo County, CA

Job type:
Contract-hire

Pay rate:
$45-$65/hr.
DOE
Role Overview
The QC Specialist (LIMS) will play a vital role in performing routine and non-routine testing to ensure product quality and regulatory compliance. This position is responsible for maintaining data integrity within the LIMS system, supporting product release, and driving continuous process improvements. The QC Specialist will collaborate cross-functionally with Quality Assurance, Manufacturing, and R&D teams.

Key Responsibilities

  • Perform analytical and functional QC testing on raw materials, in-process samples, and final product batches.
  • Enter, review, and manage data in LIMS to ensure accuracy, completeness, and traceability.
  • Author, revise, and maintain SOPs, test methods, and QC documentation in accordance with cGMP / ISO standards.
  • Support and conduct investigations for OOS (Out-of-Specification) results and deviations in collaboration with QA.
  • Assist with calibration, maintenance, and troubleshooting of laboratory equipment.
  • Contribute to method qualifications, process validations, and change control initiatives.
  • Participate in data trending, QC metrics reporting, and preparation for audits and inspections.

Qualifications
Required:

  • Bachelor's degree in Biology, Chemistry, Biochemistry, or a related scientific discipline.
  • 2–4+ years of QC experience in the biotechnology, pharmaceutical, or biomanufacturing industry.
  • Hands-on experience with LIMS for sample tracking, data entry, and workflow management.
  • Solid understanding of cGMP, GLP, and ISO 9001 quality standards.

Preferred

  • Proficiency in analytical techniques such as HPLC, ELISA, PCR, spectrophotometry, or enzymatic assays.
  • Familiarity with ERP systems, Electronic Lab Notebooks (ELN), and other digital documentation tools.
  • Experience in enzyme, protein, or biologics manufacturing environments.

Note:
This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you
INDBH

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