Microbiology Supervisor (QC Lab)

Merck•Saint Louis, MO

1d•Onsite

About The Position

The Microbiology Supervisor leads the GMP Quality Control Microbiology department, ensuring full compliance with ICH Q7 and 21 CFR regulations for active pharmaceutical ingredient (API) testing. Key responsibilities include overseeing microbiological test methods, method validations, and tech transfers; managing OOS/OOT investigations, deviations, and CAPAs; and conducting routine training on aseptic techniques and testing procedures. Supervise, manage, and develop a QC Microbiology team of 8–10 employees, holding full accountability for meeting business quality performance metrics and KPIs. Oversee the Environmental Monitoring Program and the Bioburden and Endotoxin Testing laboratories. Manage and prioritize laboratory testing schedules to ensure all products are released in a timely manner. Develop and implement programs to establish and maintain quality systems and product/service standards, while driving quality improvement initiatives and establishing policies, procedures, and methods to enhance product, material, component, process, and operational quality. Support and participate in client and regulatory audits. Interface with internal and external customers on a regular basis to communicate project status, resolve issues, and implement methods, techniques, and evaluation criteria for products and processes. Perform other duties as required by management.

Requirements

Bachelor's Degree in Microbiology, Biochemistry, Biology, or other Life Science discipline
3+ years of experience as a quality control manager, supervisor, or lead
In-depth knowledge of health authority (FDA, EMA) expectations for pharma/biotech bulk and finished product manufacturing, alongside microbiological testing requirements
Proficiency with analytical instrumentation and laboratory software
Comprehensive knowledge of ICH Q7, 21 CFR 210/211, USP, and EP pharmacopeia requirements
Proven experience working in a highly matrixed organization, preferably within a GMP manufacturing environment
Strong written and verbal communication skills, with a demonstrated ability to translate complex issues into straightforward, succinct explanations
Advanced root cause analysis and problem-solving skills
Strong computer skills, including proficiency in word processing and Quality Systems databases
Subject matter expertise in aseptic principles and practices
Strong understanding of microbiological methodology and laboratory techniques, specifically USP <85>, USP <61>, and USP <62>

Nice To Haves

Master's degree in a Life Sciences discipline
Experience as a Quality Control Supervisor or Manager at a Life Sciences organization

Responsibilities

Supervise, manage, and develop a QC Microbiology team of 8–10 employees, holding full accountability for meeting business quality performance metrics and KPIs
Oversee the Environmental Monitoring Program and the Bioburden and Endotoxin Testing laboratories
Manage and prioritize laboratory testing schedules to ensure all products are released in a timely manner
Develop and implement programs to establish and maintain quality systems and product/service standards, while driving quality improvement initiatives and establishing policies, procedures, and methods to enhance product, material, component, process, and operational quality
Support and participate in client and regulatory audits
Interface with internal and external customers on a regular basis to communicate project status, resolve issues, and implement methods, techniques, and evaluation criteria for products and processes
Perform other duties as required by management