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

Winston-Salem, North Carolina, United States

Position Title: QC Microbiology Analyst I Contractor

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.

The Environmental Monitoring (EM) Analyst supports ProKidneys Environmental Monitoring Program by performing routine and critical monitoring activities to maintain a cGMP-compliant facility. This role involves working closely with manufacturing operations, collecting environmental and utility samples, and ensuring timely documentation and reporting. The EM Analyst will work a 4/10 schedule (SundayWednesday or WednesdaySaturday), with shifts from either 06001600 or 08001800.

Essential Duties & Responsibilities:

• Perform routine Environmental Monitoring (EM) of GMP-controlled areas
• Conduct Personnel Monitoring during Manufacturing Operations
• Set up and operate EM equipment per established procedures
• Follow Standard Operating Procedures (SOPs), Work Instructions (WIs), and Protocols
• Participate in reading, revising, and training on SOPs, WIs, Forms, and Protocols
• Support QC Micro Analysts with sample receipt from Manufacturing
• Track and trend EM, Bioburden, Sterility, and Endotoxin data
• Maintain inventory levels in QC labs and coordinate material requests with the warehouse
• Perform streaking and isolation of recovered organisms
• Complete documentation accurately and in a timely manner
• Other duties as assigned

Minimum Qualifications:

• Education/Training:
  High School Diploma or greater
• Experience:
  13 years of relevant experience; prior work in a GMP facility is highly desirable
• Knowledge:
  Basic understanding of GMP regulations and cleanroom behavior
  Familiarity with microbiology lab practices is a plus
• Skills:
  Ability to read and follow schedules and instructions
  Strong organizational skills and attention to detail
  Ability to work independently and in a team environment
  Comfortable with compliance-driven work and documentation
  Proficient in Microsoft Office (Excel, Word, Visio, etc.)
  Good hand-eye coordination
  Ability to lift up to 30 pounds
  Effective verbal and written communication skills
  Dependable with a strong work ethic