QC Microbiology Specialist II — Lab Leader & SME

PCI Pharma Services; Bedford (NH); Sur place; USD 85 000 - 110 000; Plein temps

Résumé du poste

PCI Pharma Services in Bedford, NH is seeking a QC Microbiology Specialist II to perform complex microbiology testing, guide lab staff, and lead study-driven testing initiatives. The role emphasizes change control, documentation, and cGMP compliance within a fast-paced QC environment.

Requirements include a high school diploma or equivalent, with AS/BS in Microbiology preferred, and 7–9 years of cGMP lab experience.

Qualifications

• High school Diploma, GED, or equivalent; AS/BS preferred in Microbiology or related field.
• 7-9 years’ experience in a cGMP environment.

Responsabilités

• Perform non-routine complex testing and support change control processes.
• Guide others in lab routines and routine testing.
• Lead high-throughput, right-first-time work to meet production schedules.
• Lead qualification and study-directed testing activities.
• Review and evaluate advanced lab testing results; mentor team members.
• Authors/reviews/edit study protocols and related documents.
• Support investigations of OOS assays and events; ensure cGMP compliance.
• Lead LEAN lab and six sigma initiatives; act as project leader for lab projects.

Connaissances

cGMP experience

Lab testing

Project leadership

Lean Six Sigma

SME trainer

Formation

AS/BS in Microbiology

Description du poste

PCI Pharma Services in Bedford, NH is seeking a QC Microbiology Specialist II to perform complex microbiology testing, guide lab staff, and lead study-driven testing initiatives. The role emphasizes change control, documentation, and cGMP compliance within a fast-paced QC environment.

Requirements include a high school diploma or equivalent, with AS/BS in Microbiology preferred, and 7–9 years of cGMP lab experience.