PCR QC Lead: Product Release & Compliance

Bio-Rad Laboratories; Hercules (CA); On-site; USD 97,000 - 133,000; Full time

Benefits offered by this job

Competitive medical plans

Free HSA funds

401k + profit sharing

Employee stock purchase program

Parental leave

Job summary

Bio-Rad Laboratories in Hercules, CA seeks a PCR Quality Control Supervisor II to lead daily PCR QC operations, ensuring product quality and timely release. This role supports commercial manufacturing, raw material testing, stability studies, investigations, and NPIs.

The candidate will oversee staffing, training, and performance, review QC data and quality records, and collaborate across QA, MSAT, Planning, and Supply Chain to maintain uninterrupted product supply.

Qualifications

• BS in Biology, Molecular Biology, Biochemistry, Biotechnology, Chemistry, or related field (MS preferred).
• 5+ years in QC/QA/manufacturing support or regulated labs.
• 3+ years of supervisory/leadership experience.
• Experience with GMP, FDA, ISO 13485, product release testing, and manufacturing support.
• Lean/Six Sigma or continuous improvement experience preferred.
• Investigations, root cause analysis, CAPAs, and change controls experience.

Responsibilities

• Lead daily PCR QC laboratory operations and testing priorities.
• Manage staffing, training, cross-training, and performance development.
• Ensure timely review and approval of QC data, investigations, and quality records.
• Support production, NPIs, and increasing PCR business demands.
• Drive continuous improvement, productivity, and lead-time reduction.
• Partner with Manufacturing, QA, MSAT, Planning and Supply Chain to ensure uninterrupted product supply.
• Maintain compliance with FDA, ISO 13485, and quality system requirements.

Skills

qPCR

RT-PCR

ddPCR

nucleic acid testing

protein analysis

leadership

Education

BS in Biology/related field

MS preferred

Tools

SAP

ERP systems

Job description

Bio-Rad Laboratories in Hercules, CA seeks a PCR Quality Control Supervisor II to lead daily PCR QC operations, ensuring product quality and timely release. This role supports commercial manufacturing, raw material testing, stability studies, investigations, and NPIs.

The candidate will oversee staffing, training, and performance, review QC data and quality records, and collaborate across QA, MSAT, Planning, and Supply Chain to maintain uninterrupted product supply.