Manager, Quality Control Microbiology

Duties and Responsibilities

• Manage and prioritize daily microbiology laboratory operations to ensure timely execution of routine, stability, environmental monitoring, utility, and non-routine testing
• Develop and maintain laboratory testing schedules, resource plans, and personnel assignments to meet operational timelines and business priorities
• Monitor laboratory workload, testing queues, sample inventory, and capacity to ensure efficient utilization of resources and on-time delivery of results
• Ensure completion of all assigned testing activities in accordance with approved procedures, protocols, and GMP requirements
• Author, investigate, and support closure of deviations, laboratory investigations, CAPAs, and change controls and ensuring timely closure of these quality records
• Review laboratory documentation, test records, and supporting data to ensure accuracy, completeness, and compliance with GMP and data integrity requirements
• Support document revisions, and continuous improvements of laboratory procedures and documentation
• Supervise, coach, and develop microbiology personnel, including performance management, workload balancing, and day-to-day technical guidance
• Ensure personnel training, qualification, and compliance with all applicable training requirements
• Support internal audits, regulatory inspections, and client audits, and ensure the lab maintains a continuous state of inspection readiness
• Monitor laboratory performance metrics and implement actions to improve efficiency, compliance, and operational effectiveness
• Oversee equipment maintenance, calibration, qualification, and lifecycle activities to ensure continued operational readiness
• Maintain safety requirements of lab and lab personnel

Qualifications

• BS in Microbiology, biological science, or related scientific discipline
• 7+ years of related experience
• 3+ years in a management/leadership role(s)
• Experience authoring deviations, CAPAs, and change controls
• Strong knowledge of environmental monitoring, utility testing, and microbiological methods
• Working knowledge of FDA, EMA, USP, and GMP regulations
• Understanding of GMP's with expectations of a commercial GMP environment
• Must communicate effectively (verbal and written) with QC Management and peers. Written communicate skills require full competence in following detailed written instructions, creating/revising SOP's, and reports
• Hands on skills and knowledge of quality lab operations including the operation and troubleshooting of lab equipment
• Advanced knowledge of basic chemical and biological safety procedures/precautions
• Proficient in Microsoft Office – Outlook, Word, Excel, PowerPoint

Working Conditions

• Laboratory environment/equipment working within Microbiology
• Personal Protective Equipment must be worn as required
• Normal office working conditions: computer, phone, files, fax, copier
• Pace may be fast and job completion demands may be high

Physical Requirements

• Frequent lifting up to 10 lbs
• Frequent standing/walking to work in lab environment for extended periods
• Frequent sitting for extended periods to use computer