Life Science Jobs Astrix- Apply for QC Specialist Role
A top biotechnology company in San Mateo County, CA is seeking a QC Specialist (LIMS) to ensure product quality and regulatory compliance. This contract-hire role offers hands-on experience in LIMS management, QC workflows, and cross-functional collaboration with Quality Assurance, Manufacturing, and R&D teams. Candidates with experience in biotechnology, pharmaceutical, or biomanufacturing industries are encouraged to apply.
About the Company
Astrix is a leading biotechnology staffing and consulting firm that connects top scientific talent with cutting-edge life sciences companies. With a focus on quality, innovation, and career development, Astrix helps professionals advance in biotechnology, pharmaceuticals, and biomanufacturing industries while enabling companies to access specialized expertise for critical roles.
- Job Title: QC Specialist
- Location: San Mateo County, CA
- Job Type: Contract-hire
Life Science Jobs Astrix- Role
The QC Specialist (LIMS) will perform routine and non-routine QC testing, maintain data integrity in the LIMS system, support product release, and drive continuous process improvements. This position collaborates closely with QA, Manufacturing, and R&D teams, ensuring compliance with cGMP, GLP, and ISO 9001 standards.
Life Science Jobs Astrix- Key Responsibilities:
- Lead and support LIMS design, configuration, and implementation for QC workflows.
- Collaborate with QC, QA, IT, and external vendors to define user requirements and functional specifications.
- Author and execute IQ/OQ/PQ validation protocols following 21 CFR Part 11 and GxP compliance.
- Develop and deliver training materials for QC users; provide ongoing post-implementation support.
- Ensure LIMS integration with other lab systems (CDS, ELN, ERP) to streamline workflows.
- Monitor system performance and lead continuous improvement initiatives.
- Maintain change control documentation and participate in audits as the LIMS subject matter expert.
QC Specialist Role- Qualifications:
Required:
- Bachelor’s degree in Biology, Chemistry, Biochemistry, or related discipline.
- 2–4+ years of QC experience in biotechnology, pharmaceutical, or biomanufacturing.
- Hands-on experience with LIMS for sample tracking and workflow management.
- Solid understanding of cGMP, GLP, and ISO 9001 quality standards.
Preferred:
- Proficiency in analytical techniques like HPLC, ELISA, PCR, spectrophotometry, or enzymatic assays.
- Familiarity with ERP systems, Electronic Lab Notebooks (ELN), and digital documentation tools.
- Experience in enzyme, protein, or biologics manufacturing environments.
Compensation & Work Type:
- Contract-hire role
- Pay rate: $45–$65/hour DOE
Why Apply:
This is an exciting opportunity to join a leading biotech company and play a critical role in QC operations and LIMS management, contributing to the quality and safety of cutting-edge biotechnology products.
