QC Microbiology Analyst 1

ProKidney•Winston-Salem, NC

11h

About The Position

The QC Microbiology Analyst I supports ProKidney’s QC Microbiology department by performing routine environmental monitoring and microbiological testing. The role works closely with manufacturing and support operations to collect and test environmental and utility samples and ensure timely documentation and reporting. The position follows a 5/8 schedule, either Sunday–Thursday or Monday–Friday, with weekend and holiday support. Shift options are 0700–1600, 0800–1700, or 1030–1930. The role requires adherence to cGMP requirements and cleanroom hygiene standards, and includes laboratory testing, documentation, inventory coordination, and support for procedures, training, and lean initiatives.

Requirements

High school diploma or greater.
1–2 years of relevant experience.
Basic understanding of GMP regulations and cleanroom behavior.
Basic understanding of cGMP microbiology laboratory practices.
Ability to read and follow schedules and instructions.
Strong organizational skills and attention to detail.
Ability to work independently and in a team environment.
Comfort with compliance-driven work and documentation.
Proficiency in Microsoft Office, including Excel, Word, and Visio.
Good hand-eye coordination.
Ability to lift up to 30 pounds; bending, lifting, and squatting are required.
Effective verbal and written communication skills.
Dependability and a strong work ethic.
Must be eligible to work in the United States without requiring work visa or residency sponsorship.

Nice To Haves

Prior work in a GMP facility is highly desirable.
Familiarity with LIMS.

Responsibilities

Perform routine Environmental Monitoring (EM) of GMP-controlled areas.
Support Personnel Monitoring during manufacturing operations.
Perform microbiological testing on samples, including bioburden, endotoxin, and sterility testing.
Follow SOPs, Work Instructions, protocols, and safety requirements, and document laboratory work consistent with cGMP requirements.
Participate in revising and providing training on SOPs, Work Instructions, forms, and protocols.
Support lean initiatives related to lab operations, standard work, test method execution, documentation updates, and equipment qualification.
Maintain QC laboratory inventory and coordinate material requests with the warehouse.
Perform enumeration, gram staining, streaking, and isolation of recovered organisms.
Complete documentation accurately and in a timely manner.
Maintain the high hygiene standards required for cGMP cleanroom operations.
Perform other duties as assigned.