Quality Control Manager: cGMP Audits & Team Leadership

Guest Supply; Rahway (NJ); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

Gilchrist & Soames is seeking a Quality Control Manager to oversee the QC program ensuring products, services, and processes meet required quality standards and customer requirements. The role leads QC staff, develops SOPs, and coordinates audits, with cross-functional collaboration across production, engineering, and R&D.

The ideal candidate has 5+ years in QC, leadership experience, and a strong background in cGMP and microbiology, plus relevant certifications.

Qualifications

• Bachelor’s degree in biology, microbiology, or life sciences, or 10 years in Quality Control.
• Experience leading quality initiatives, participating in audits, and developing CAPA responses.
• QCA certification is a plus; Six Sigma is a plus.

Responsabilités

• Oversee daily workload and safety of QC staff; manage staffing actions and evaluations.
• Develop, revise, and review SOPs, qualification/validation protocols and reports.
• Oversee QC program operations including inspections, tests, and audits; back-up testing as needed.
• Conduct internal/external QC audits to ensure standards compliance.
• Identify and investigate QC issues; address deviations and drive improvements.
• Collaborate with production, engineering, and R&D to integrate QC in design and production.

Connaissances

Analytical skills

Communication

Quality systems

MS Office

Statistical tools

Team leadership

Problem solving

Project management

Attention to detail

Formation

Bachelor’s degree in biology/microbiology or life sciences

Quality certifications (QCA)

Six Sigma Certification

Outils

MS Office

Description du poste

Gilchrist & Soames is seeking a Quality Control Manager to oversee the QC program ensuring products, services, and processes meet required quality standards and customer requirements. The role leads QC staff, develops SOPs, and coordinates audits, with cross-functional collaboration across production, engineering, and R&D.

The ideal candidate has 5+ years in QC, leadership experience, and a strong background in cGMP and microbiology, plus relevant certifications.