GMP QC Microbiology Lead

Actalent; United States; Hybrid; USD 109,000 - 120,000; Full time

Benefits offered by this job

Medical coverage

401(k)

Career growth

Job summary

Actalent is seeking a Sr QC Microbiologist to provide technical leadership in a growing pharmaceutical microbiology laboratory in Jupiter, FL. The role focuses on GMP-compliant operations for product and API release, stability studies, and expansion of testing capabilities.

The candidate will oversee method validation, environmental monitoring, and regulatory compliance, while mentoring QC analysts and coordinating with QA during investigations and inspections.

Qualifications

• Bachelor's degree in Microbiology or a related science field.
• At least seven years of GMP pharmaceutical microbiology experience.
• Strong technical writing, equipment qualification, and lab validation experience.
• Experience supporting regulatory inspections and client audits.

Responsibilities

• Provide technical leadership for the analytical microbiology laboratory.
• Lead the selection, qualification, and implementation of analytical instrumentation (IQ/OQ/PQ).
• Develop and maintain SOPs, lab protocols, reports, and training programs.
• Establish environmental monitoring programs for cleanrooms and related facilities.
• Coordinate with QA to support investigations, CAPAs, and cGMP compliance.
• Support client interactions and regulatory audits as the SME in microbiology.

Skills

Microbiology

Environmental monitoring

Aseptic technique

Bioburden

Sterility

Regulatory compliance

Technical leadership

Communication skills

Education

Bachelor's degree in Microbiology

Master's degree preferred

Tools

IQ/OQ/PQ

GxP instrumentation

Job description

Actalent is seeking a Sr QC Microbiologist to provide technical leadership in a growing pharmaceutical microbiology laboratory in Jupiter, FL. The role focuses on GMP-compliant operations for product and API release, stability studies, and expansion of testing capabilities.

The candidate will oversee method validation, environmental monitoring, and regulatory compliance, while mentoring QC analysts and coordinating with QA during investigations and inspections.