Kelly Services - Winston-Salem, NC
posted 24 days ago
Full-time - Mid Level
Winston-Salem, NC
Administrative and Support Services
About the position
The QC Microbiology Manager is responsible for overseeing the quality control microbiology testing programs and personnel in a growing company located in Winston Salem, NC. This role involves managing daily operations, ensuring compliance with regulatory standards, and contributing to positive patient outcomes through effective leadership and collaboration with product development teams.
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
- BS in Microbiology, Biology, or a related scientific discipline.
- 7-10 years of relevant experience in a GMP setting, with previous supervisory experience preferred.
- Strong knowledge of GMP, FDA, and EMA regulatory requirements.
- Familiarity with industry trends and the latest technologies in microbiology.
- 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.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Telemedicine
- Term life insurance
- Whole life insurance
- Accident insurance
- Critical illness insurance
- Legal plan
- Short-term disability
- Retirement savings plan
- Service bonus
- Holiday pay plans
- Transit spending account
- Paid sick leave
