QC Manager

Frontage Laboratories

📍 Exton, Pennsylvania, United States

Full Time Operations Specialties Managers

Job Description

Job Description: QC Manager – Biomarker and Biologics Laboratory

Job Title: Quality Control (QC) Manager
Department: Biomarker & Biologics
Location: Exton, PA (Onsite)

Position Summary

The QC Manager is responsible for oversight of the Quality Control function supporting compliant biologics and biomarker testing performed using ligand-binding assay (LBA) platforms and other immunoassay. This role ensures that study data, assay performance, regulated documentation, and reporting meet GLP, data integrity, and client requirements. The QC Manager leads a team of QC reviewers responsible for data verification, review of assay outputs, documentation accuracy, and compliance across all GLP bioanalytical studies. 

Key Responsibilities

Oversight for Bioanalytical LBA Studies

  • Ensure QC activities adhere to GLP regulations (FDA 21 CFR Part 58, OECD GLP) and bioanalytical industry expectations (FDA/E...
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