Quality Control Supervisor, Microbiology

The Supervisor, QC Microbiology reports to the Manager, QC Microbiology. This position provides day-to-day supervisory oversight of the QC Microbiology team, ensuring all testing, environmental monitoring, and documentation activities are completed in compliance with cGMP requirements, schedules, and quality standards. The Supervisor combines direct supervisory responsibilities with hands-on technical expertise. 

Job Responsibilities 

Core Responsibilities 

• Supervise day-to-day activities of QC Microbiology Analysts including scheduling, workload assignment, and performance oversight. 

• Identify staffing gaps and escalate resource needs to the Manager. 

• Oversee the accurate and timely execution of all QC Microbiology testing including LAL/Endotoxin, Bioburden, Sterility, Biological Indicator testing, Microbial Identification, and Environmental Monitoring. 

• Ensure laboratory operations are conducted in compliance with cGMPs, SOPs, and safety standards at all times. 

• Manage equipment and reagent resources to ensure uninterrupted testing operations. 

• Manage equipment qualification, calibration, and maintenance schedules. 

Quality Systems & Documentation 

• Approve records and data as required per current procedures. 

• Oversee and approve deviation investigations, OOS investigations, CAPAs, and Change Controls in a timely manner. 

• Author and review SOPs, Test Methods, and training modules. 

• Oversee EM trending programs and approve reports per schedule. 

• Manage risk-based assessments and justifications for classified area qualifications. 

• Support regulatory inspections and client audits. 

Training & Development 

• Provide technical guidance, coaching, and performance feedback to direct reports. 

• Support onboarding and training of new team members in GMP practices and laboratory procedures. 

• Act as a certified OJT trainer for assigned equipment and process tasks. 

• Ensure team members acquire and maintain all required qualifications and certifications for the assigned work area. 

Minimum Qualifications 

• Advanced knowledge of QC Microbiology operations including environmental monitoring, sterility testing, endotoxin testing, and microbial identification. 

• Demonstrated supervisory experience including scheduling, performance oversight, and development of direct reports. 

• Demonstrated experience managing GMP laboratory operations including documentation control, equipment qualification, and deviation management. 

• In-depth knowledge of cGMP requirements and compendial standards applicable to sterile manufacturing. 

• Strong leadership, communication, and interpersonal skills. 

• Ability to manage multiple priorities and make timely decisions in a fast-paced environment. 

• Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language. 

Preferred Qualifications 

• Bachelor's degree or higher in Microbiology, Life Sciences, or a related scientific discipline. 

• 5+ years of progressive QC Microbiology experience, including at least 1-2 years in a supervisory or lead capacity within a GMP-regulated biopharmaceutical or pharmaceutical environment. 

• Experience with industry-specific computerized applications (e.g., Veeva, Novatek, SAP). 

• Experience with method validation and technology transfer. 

• Knowledge of US and international GMPs including Health Canada, FDA, and EMA/EU Annex 1 requirements and compendial standards (USP, EP). 

• Experience supporting regulatory inspections (e.g., Health Canada, FDA). 

Physical & Work Environment  

• Work may involve extended hours, including evenings and weekends, depending on project deadlines and operational needs. 

• Physical demands may include standing for extended periods, ability to lift up to 10 lbs related to environmental monitoring, and working in cleanroom environments with appropriate gowning requirements. 

• Pre-employment medical and medical re-examination: inclusive of eye examinations and color blindness tests, performed every 2 years or as per RESILIENCE's SOPs.

• This position requires vaccination for Hepatitis A and B