ProKidney
QC Microbiology Analyst 3
Winston-Salem, North Carolina, United States · Mid
Work authorization requiredDetected 26 days ago
ExcelGMPMedical DevicesCommunicationMentoringWritingOrganizational SkillsMicrosoft Office
About the role
- 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.
- Shifts from either 0700-1600, 0800-1700 or 1030-1930.
- Generate and present metrics and trends for Management Review.
Responsibilities
- 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.
- Support and internal and external audits.
- Support training on Good Documentation Practices, Data Integrity, and Change Management.
- Review and maintain SOPs, Work Instructions, Validation studies, Risk Assessments and protocols.
- Operate, maintain and troubleshoot EM and laboratory equipment
Requirements
- Analytical mindset with ability to trend data and identify improvement opportunities.
Nice to have
- Bachelor's degree in a science or technical discipline preferred, or equivalent experience.
- Experience with commercial manufacturing and cleanroom monitoring strongly preferred.
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
- Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
- Competence with Microsoft Office (Excel, Word, Visio); LIMS or data tracking systems a plus
Benefits
- The Analyst III will work a 5/8 schedule (Sunday-Thursday or Monday-Friday), with weekend and holiday support.
Visa & Work Authorization
- Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
Apply directly at ProKidney →Create a free account for alerts like thisView ProKidney immigration profile
This listing is sourced directly from ProKidney's careers page and normalized into a canonical job model.