Summary:
This is a direct hire full time position for a QC Manager, Microbiology in Winston Salem NC. This is an excellent opportunity to join a growing company and contribute to positive patient outcomes.

Location: Winston Salem NC

Responsibilities:

• Manage the QC Microbiology testing programs and personnel, including overseeing daily operations and weekly testing schedules.
  

• Collaborate with Product Development to ensure the timely completion of required sample testing.
  

• Review and approve QC testing forms, ensuring compliance with protocols and regulatory standards.
  

• Oversee the status changes of raw materials in the ERP system and issue raw materials for testing.
  

• Serve as the subject matter expert for microbiology assays, providing guidance and troubleshooting assistance.
  

• Ensure cGMP compliance within the department and represent QC during audits, inspections, and cross-functional project teams.
  

• Write and review technical documents, protocols, and reports to maintain accuracy and clarity.
  

• Lead daily operations in the lab and clean rooms, ensuring safety, quality, and compliance with all QC requirements.
  

• Monitor and coach staff to ensure compliance with GMP and quality system standards.
  

• Oversee the timely completion of document reviews for the on-time release of clinical lots.
  

• Maintain quality control labs to ensure they are inspection-ready and well-maintained at all times.
  

• Provide training and development for staff to ensure up-to-date knowledge and skills.
  

• Perform additional duties as required.

Requirements:

• Education/Training: BS in Microbiology, Biology, or a related scientific discipline.
  

• Experience: 7-10 years of relevant experience in a GMP setting, with previous supervisory experience preferred.
  

• Knowledge:
  

  • Strong knowledge of GMP, FDA, and EMA regulatory requirements.
    

  • Familiarity with industry trends and the latest technologies in microbiology.
    

  
  

• Skills:
  

  • Subject matter expert in quality control microbiology assays, including sterility testing and endotoxin testing.
    

  • Proficient in aseptic practices, clean room operations, and cGMP requirements.
    

  • Strong organizational, time management, and multitasking skills, with the ability to prioritize projects and meet deadlines.
    

  • Excellent problem-solving, decision-making, and critical thinking abilities.
    

  • Effective written and verbal communication skills for reporting and collaboration.
    

  • Experience with budget preparation, project facilitation, and employee training.
    

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