QC Manager

General Description

Oversee a team of QC Analysts and maintain the QC Laboratory in a state of cGMP compliance.

• Train, coach, and develop QC staff.
• Develop, revise, and review SOPs, qualification/validation protocols, and reports.
• Write deviations, CAPAs, and own change controls; review/guide deviations/CAPAs from QC Analysts.
• Review invalid assays and lead invalid assay investigations.
• Participate in OOS investigations.
• Ensure analytical data is initiated on time and completed within established TATs.
• Review QC documentation (equipment logbooks, solution prep records, cell line records, TRFs, etc.).
• Ensure test results are entered into appropriate reports.
• Track/trend reference standards, assay control, and critical reagents.
• Track equipment cleaning, preventive maintenance, and calibration schedules.
• Review equipment IQ/OQ/PQ documentation (IOQs) and re-qualifications.
• Drive QC process/procedure continuous improvements.

• BS in Biological Sciences, Bioengineering, or Chemistry.
• 7+ years performing QC activities in pharmaceutical/biotech under GMP guidelines across multiple disciplines/assays.
• 2+ years supervisory experience.
• Advanced QC testing experience in pharmaceutical/biopharmaceutical labs.
• Familiarity with qPCR, HPLC, ELISA, and cell-based assays.

• Manage teams and work independently; review data and provide summary analysis.
• Support regulatory/client audits and interact with clients.
• Strong collaboration, negotiation, communication (verbal/written).
• Self-motivated, proactive, accountable, flexible; mentor key employees.
• High attention to detail, strong documentation, scientific/analytical problem-solving.
• Comfortable in fast-paced small company environment with shifting priorities.