QC Microbiology Analyst 3

Merck & Co.; 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

Winston-Salem, North Carolina, United States

Position Summary

Join us in developing pioneering therapies that aim to transform the treatment of Chronic Kidney Disease (CKD) and change patients' lives. Our technology is designed to treat diseased kidneys using a patient's own cells, potentially preventing or delaying the need for dialysis or transplant.

Quality Control (QC) Microbiology Analyst III provides support and execution on ProKidney’s Environmental Monitoring and Microbiological testing, maintaining GMP compliance, and mentoring junior analysts. This role involves monitoring during manufacturing operations, routine EM and utilities, root‑cause analysis of excursions, and documentation and continuous improvement within the QC Microbiology team. The Analyst III will work a 5/8 schedule (Sunday‑Thursday or Monday‑Friday), with weekend and holiday support. Shifts from either 0700‑1600, 0800‑1700 or 1030‑1930.

Essential Duties and Responsibilities

• Perform Change Control and CAPA investigations, ensuring timely closure, impact assessments, and regulatory compliance.
• Support and internal and external audits.
• Generate and present metrics and trends for Management Review.
• Support training on Good Documentation Practices, Data Integrity, and Change Management.
• Review and maintain SOPs, Work Instructions, Validation studies, Risk Assessments and protocols.
• Participate in continuous improvement initiatives, harmonization efforts, and risk assessments related to quality control.
• Perform Routine Environmental Monitoring (EM) of classified GMP areas
• Conduct Personnel Monitoring during Aseptic Manufacturing Operations and EMPQ activities
• Operate, maintain and troubleshoot EM and laboratory equipment
• Adhere to Standard Operating Procedures (SOPs), Work Instructions (WIs), Protocols and safety requirements and document laboratory work consistent with cGMP requirements
• Participate in revising, training on SOPs, WIs, Forms, and Protocols
• Supports lean initiatives in the area of lab operations, standard work, test method execution, documentation updates and equipment qualification

Minimum Qualifications

Education/Training

• Bachelor’s degree in a science or technical discipline preferred, or equivalent experience.

Experience

• 3-5 years of progressive experience in quality systems within regulated pharma, biotech, or medical device industries.
• Experience with commercial manufacturing and cleanroom monitoring strongly preferred.

Knowledge

• Strong working knowledge of quality systems operations (Deviations, CAPA, Change Control, Training, Complaints, Document Control).
• Excellent technical writing, training, and communication skills.
• Analytical mindset with ability to trend data and identify improvement opportunities.

Skills

• Strong attention to detail and organizational skills
• Ability to work independently
• Competence with Microsoft Office (Excel, Word, Visio); LIMS or data tracking systems a plus
• Comfortable performing tasks in a cleanroom setting and wearing PPE for extended periods
• Strong written and verbal communication skills
• Hands-on experience with electronic QMS, particularly MasterControl (system administration and process ownership).
• Hand-on experience with LIMS or sample management programs
• Ability to lift up to 30 pounds and maintain good hand-eye coordination. Bending, lifting and squatting required.

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.