QC Microbiology Analyst III: EM, CAPA & GMP Expert

ProKidney; Winston-Salem (NC); On-site; USD 60,000 - 80,000; Full time

Job summary

ProKidney is seeking a Quality Control Microbiology Analyst III in Winston-Salem, NC. This role supports environmental monitoring and microbiological testing, maintaining GMP compliance, and mentoring junior analysts. Responsibilities include conducting audits, generating metrics, and continuous improvement within the QC team. Candidates should have a Bachelor's in a science discipline and 3-5 years of relevant experience. Strong skills in quality systems and communication are essential. ProKidney offers an inclusive work environment with a focus on patient care.

Qualifications

• 3-5 years of experience in quality systems within regulated industries.
• Experience with commercial manufacturing and cleanroom monitoring preferred.
• Strong working knowledge of quality systems operations (Deviations, CAPA, Change Control).

Responsibilities

• Perform Change Control and CAPA investigations.
• Support internal and external audits.
• Generate metrics and trends for Management Review.
• Conduct Routine Environmental Monitoring of GMP areas.
• Document laboratory work consistent with cGMP requirements.

Skills

Attention to detail

Organizational skills

Technical writing

Analytical mindset

Microsoft Office

Hands-on experience with electronic QMS

Cleanroom experience

Education

Bachelor’s degree in a science or technical discipline

Tools

LIMS

Microsoft Excel

Microsoft Word

MasterControl

Job description

ProKidney is seeking a Quality Control Microbiology Analyst III in Winston-Salem, NC. This role supports environmental monitoring and microbiological testing, maintaining GMP compliance, and mentoring junior analysts. Responsibilities include conducting audits, generating metrics, and continuous improvement within the QC team. Candidates should have a Bachelor's in a science discipline and 3-5 years of relevant experience. Strong skills in quality systems and communication are essential. ProKidney offers an inclusive work environment with a focus on patient care.