QC Microbiology Supervisor

Guerbet; Raleigh (NC); Presencial; USD 70.000 - 90.000; Jornada completa

Descripción de la vacante

Guerbet is looking for a QC Microbiology Supervisor in Raleigh, NC to manage the Quality Control Microbiology Laboratory. This key role ensures the integrity of microbiological testing across materials and products.

The ideal candidate will have 7-10+ years of microbiology lab experience and 3-5 years in a leadership position, demonstrating strong leadership skills and in-depth regulatory knowledge.

Formación

• 7–10+ years of hands-on microbiology lab experience in a regulated manufacturing environment.
• 3–5 years in a supervisory or leadership role.
• In-depth knowledge of GMP, FDA, USP, and other regulatory standards.

Responsabilidades

• Lead and manage microbiological testing operations.
• Ensure compliance with USP, FDA, and other applicable regulatory standards.
• Train and mentor analysts on procedures and regulatory requirements.

Conocimientos

Leadership

Data analysis

Communication skills

Attention to detail

Microbiology lab experience

Educación

Bachelor’s degree in Microbiology, Biology, or related discipline

Herramientas

Laboratory Information Management Systems (LIMS)

Descripción del empleo

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