We’re seeking a detail-oriented and experienced QC Microbiology Supervisor to lead the daily operations of our Quality Control Microbiology Laboratory. This role is critical to ensuring the integrity of microbiological testing across raw materials, in-process samples, finished products, and environmental monitoring. You’ll collaborate cross-functionally with teams in manufacturing, engineering, validation, and packaging to uphold quality standards and resolve issues efficiently. The ideal candidate brings strong leadership, technical expertise, and a proactive mindset to drive continuous improvement and regulatory compliance. This is an on-site position located in Raleigh, NC.
YOUR ROLE:
Lead and manage microbiological testing operations, including environmental monitoring and validation activities
Supervise biological assays and testing of raw materials, in-process samples, finished products, and packaging components
Ensure compliance with USP, FDA, and other applicable regulatory standards
Investigate atypical results, instrument malfunctions, and methodology issues; lead root cause analysis and corrective actions
Oversee data accuracy and perform trend analysis to identify potential quality concerns
Train and mentor analysts on procedures, techniques, and regulatory requirements
Maintain audit-ready lab conditions and manage inventory of supplies and reagents
Author and revise SOPs, specifications, and other controlled documents
Represent the microbiology department in cross-functional initiatives such as Kaizen and Lean Sigma
Participate in QA functions including OOS investigations, exception reporting, audits, and validation activities
YOUR BACKGROUND
Education
Bachelor’s degree in Microbiology, Biology, or a related scientific discipline (advanced degree preferred)
Experience
7–10+ years of hands-on microbiology lab experience in a regulated manufacturing environment
3–5 years in a supervisory or leadership role
Strong leadership, organizational, and communication skills
In-depth knowledge of GMP, FDA, USP, and other regulatory standards
Ability to work independently with minimal supervision
Proficiency in data analysis and Laboratory Information Management Systems (LIMS)
High attention to detail and a commitment to continuous improvement
Seniority level: Mid-Senior level
Employment type: Full-time
Job function:
Management and Science
Industries : Pharmaceutical Manufacturing
Benefits:
Medical insurance
Vision insurance
401(k)
