QC Microbiologist

Job Description

Job Description

We are seeking an experienced Head of Microbiology to lead microbiological operations within a pharmaceutical manufacturing facility specializing in injectables, sterile manufacturing, and clean room environments. This role is responsible for ensuring compliance with FDA and GMP regulations while overseeing sterility assurance, environmental monitoring, aseptic practices, and microbiological testing programs.

Location: Boca Raton, FL

Salary: $110k– $140,000 per year

Key Responsibilities:

• Lead, manage, and supervise the microbiology team

• Oversee microbiological testing activities including sterility, BET, bioburden, and microbial limit testing (MLT)

• Support injectable manufacturing operations and aseptic processing activities

• Oversee Environmental Monitoring (EM) programs and clean room compliance

• Prepare and review SOPs, validation protocols, qualification reports, and microbiological test methods

• Support media fill studies and sterility assurance programs

• Conduct testing of raw materials, packaging materials, and utility systems

• Manage quality systems including deviations, CAPA, OOS investigations, change controls, complaints, and recalls

• Support internal and external audits and ensure compliance with FDA and GMP regulations

• Provide technical expertise for sterile manufacturing and injectable production processes

• Train and qualify microbiology staff and ensure compliance with quality standards

Requirements:

• Bachelor’s or Master’s degree in Microbiology or related life sciences field

• 10+ years of pharmaceutical microbiology experience

• Prior experience in injectable manufacturing and sterile pharmaceutical environments required

• Strong experience with aseptic processing, clean rooms, environmental monitoring, and sterility assurance

• Strong knowledge of FDA regulations, GMP guidelines, and quality systems

• Proven leadership and team management experience

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