QC Microbiology Analyst III

Responsibilities

• Perform Change Control and CAPA investigations, ensuring timely closure and regulatory compliance
• Support 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
• 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 SOPs, Work Instructions, Protocols, and safety requirements
• Support lean initiatives in lab operations, standard work, and equipment qualification

Requirements

• Bachelor’s degree in a science or technical discipline preferred
• 3-5 years of progressive experience in quality systems within regulated pharma, biotech, or medical device industries
• Strong working knowledge of quality systems (Deviations, CAPA, Change Control, Training, Complaints, Document Control)
• Hands-on experience with electronic QMS, particularly MasterControl
• Hands-on experience with LIMS or sample management programs
• Ability to work in a cleanroom setting wearing PPE for extended periods
• Ability to lift up to 30 pounds and perform physical tasks like bending and squatting

Preferred Qualifications

• Experience with commercial manufacturing and cleanroom monitoring
• Competence with Microsoft Office (Excel, Word, Visio)

About the Company

ProKidney is developing pioneering therapies designed to treat diseased kidneys using a patient's own cells, aiming to transform the treatment of Chronic Kidney Disease (CKD).