QC Microbiologist

Engramec; Town of Florida (NY); On-site; USD 90,000 - 150,000; Full time

Job summary

Eagle Labs, Inc. seeks a Quality Control Microbiology Supervisor to oversee daily microbiology lab operations and a team of analysts. The role covers sterility, bioburden, endotoxin testing, and environmental monitoring, ensuring GMP compliance and data integrity.

Responsibilities include leading OOS investigations, CAPA implementation, and support for method verification and audits, with a focus on leading the team and maintaining quality systems.

Qualifications

• Bachelor's degree in microbiology, Biology, or closely related life science discipline.
• Minimum 5 years of hands-on experience in a cGMP pharmaceutical or biotech microbiology laboratory.
• At least 3 years in a lead or supervisory capacity.
• Advanced understanding of aseptic processing, cleanroom behaviors, and compendial requirements (USP, EP, JP).
• Strong problem-solving, data trending capabilities, and excellent verbal and written communication skills.

Responsibilities

• Team Leadership & Development: supervise, train, and mentor laboratory analysts; manage scheduling and evaluations.
• Testing Oversight: supervise routine microbiological assays including sterility, bioburden, endotoxins, and MALDI-TOF identification.
• Environmental Monitoring (EM): approve EM data, analyze trending reports, monitor cleanroom utilities to ensure compliance.

Skills

Team leadership

Data trending

Communication

Aseptic processing

Cleanroom practices

Regulatory compliance

Root-cause investigations

OOS investigations

Education

Bachelor's degree in microbiology or life sciences

Job description

Quality Control (QC) Microbiology Supervisor oversees daily microbiology laboratory operations and a team of analysts. They ensure all testing—such as sterility, bioburden, endotoxin, and environmental monitoring—complies with strict adherence to the GMP regulations. This role spans method validation, root-cause investigations, and data integrity verification.

Key Duties:

These are only highlighted by major key duties. Other requested duties assigned by Eagle Labs, Inc for job function by Quality Control Manager, Director of Laboratory Operations, or Executive leadership.

• Scheduling, conducting OOS (Out-of-Specification) investigations, and managing staff training scheduling, conducting investigations, and managing staff training.
• Supervises routine testing, including sterility testing, bacterial endotoxins (BET), bioburden, microbial limits, and growth promotion of media.
• Support assay method verification, transfer, and equipment qualification within the Laboratory.
• Act as a subject matter expert (SME) during internal audits and regulatory inspections.
• Lead Out-of-Specification (OOS) investigations, initiate Corrective and Preventive Actions (CAPA), and implement change controls.

Core Responsibilities:

• Team Leadership & Development: Supervise, train, and mentor laboratory analysts. Manage scheduling, performance evaluations, and gowning/aseptic qualifications.
• Testing Oversight: Oversee and review routine microbiological assays, including sterility, bioburden, bacterial endotoxins (LAL), microbial identification (e.g., MALDI-TOF), and water testing.
• Environmental Monitoring (EM): Approve EM data, analyze trending reports, and monitor classified cleanroom utilities to maintain compliance.

Qualifications & Requirements

• Education: Bachelor’s degree in microbiology, Biology, or a closely related life science discipline.
• Experience: Minimum 5 years of hands‑on experience in a cGMP pharmaceutical or biotech microbiology laboratory, including at least 3 or more years in a lead or supervisory capacity.
• Technical Skills: Advanced understanding of aseptic processing, cleanroom behaviors, and compendial requirements (USP, EP, JP).
• Soft Skills: Strong problem-solving, data trending capabilities, and excellent verbal and written communication skills.