QC Specialist (LIMS Implementation)

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

• Lead and support the design, configuration, and implementation of LIMS to support QC workflows (e.g., sample management, test execution, results reporting, data tracking).
• Collaborate with QC, QA, IT, and external vendors to define and document user requirements and functional specifications.
• Author and execute validation protocols (IQ / OQ / PQ) in accordance with 21 CFR Part 11 and GxP compliance requirements.
• Develop and deliver training materials for QC users and provide ongoing support post-implementation.
• Ensure LIMS integration with other lab systems (e.g., CDS, ELN, ERP) to streamline data flow and reduce manual entry.
• Monitor system performance and lead continuous improvement efforts for LIMS functionality and QC data workflows.
• Maintain change control documentation and participate in audits and inspections as the LIMS subject matter expert.
• Lead and support the design, configuration, and implementation of LIMS to support QC workflows (e.g., sample management, test execution, results reporting, data tracking).
• Collaborate with QC, QA, IT, and external vendors to define and document user requirements and functional specifications.
• Author and execute validation protocols (IQ / OQ / PQ) in accordance with 21 CFR Part 11 and GxP compliance requirements.
• Develop and deliver training materials for QC users and provide ongoing support post-implementation.
• Ensure LIMS integration with other lab systems (e.g., CDS, ELN, ERP) to streamline data flow and reduce manual entry.
• Monitor system performance and lead continuous improvement efforts for LIMS functionality and QC data workflows.
• Maintain change control documentation and participate in audits and inspections as the LIMS subject matter expert.

Qualifications

Required :

Preferred :

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