QC Microbiology Analyst 3 in Winston-Salem, North Carolina at PROKIDNEY

Winston-Salem, North Carolina, United States

Position Title: QC Microbiology Analyst 3

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 ProKidneys 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 (SundayThursday or Monday-Friday), with weekend and holiday support. Shifts from either 07001600, 08001700 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, and 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:

• Bachelors 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.