QC Microbiology Supervisor

Guerbet; Raleigh (NC); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A pharmaceutical manufacturing company based in Raleigh, NC, is seeking a detail-oriented QC Microbiology Supervisor to oversee microbiological testing operations. The position requires 7–10 years of lab experience, including supervisory roles, ensuring compliance with GMP and FDA standards. This role offers opportunities for leadership and continuous improvement in a fast-paced environment.

Qualifications

• 7–10+ years of microbiology lab experience in regulated manufacturing.
• 3–5 years in a supervisory role.
• In-depth knowledge of GMP, FDA, and USP regulations.

Responsibilities

• Lead microbiological testing operations and ensure compliance.
• Investigate atypical results and lead corrective actions.
• Train and mentor analysts on procedures and regulatory requirements.

Skills

Leadership

Data analysis

Communication

Attention to detail

GMP knowledge

Regulatory compliance

Education

Bachelor's degree in Microbiology or related field

Tools

Laboratory Information Management Systems (LIMS)

Job description

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)