QC Microbiology Analyst 1

ProKidney Corp.; Winston-Salem (NC); On-site; USD 42,000 - 66,000; Full time

Job summary

ProKidney Corp. is seeking a QC Microbiology Analyst I to support the QC Microbiology department with routine environmental monitoring and microbiological testing.

The role involves collaboration with manufacturing and support operations, collecting and testing samples, and documenting results in a timely manner. The position requires 1–2 years of relevant experience, basic GMP knowledge, and proficiency in Microsoft Office.

Qualifications

• Education: High School Diploma or higher.
• 1-2 years of relevant experience; GMP facility desirable.
• Understanding of GMP/cGMP microbiology lab practices.
• Familiarity with LIMS is a plus.
• Strong documentation and attention to detail required.

Responsibilities

• Perform routine Environmental Monitoring in GMP areas.
• Support personnel monitoring during manufacturing operations.
• Test microbiological samples (bioburden, endotoxin, sterility).
• Follow SOPs/WIs/Protocols; document work per cGMP.
• Assist in SOP/WI revisions and training; ensure timely reports.
• Maintain QC lab inventories and coordinate material requests.
• Perform basic microbiology tasks and organism isolation.
• Maintain hygiene standards for cleanrooms; meet safety requirements.
• Other duties as assigned.

Skills

Read schedules

Attention to detail

Independent worker

Team player

Documentation

Lab dexterity

Education

High School Diploma or higher

Tools

LIMS

Microsoft Office

Job description

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 I supports ProKidney’s QC Microbiology department performing Routine Environmental Monitoring and Microbiological testing. This role involves working closely with manufacturing and support operations, collecting and testing environmental and utility samples, and ensuring timely documentation and reporting. The Analyst will work a 5/8 schedule (Sunday-Thursday or Monday-Friday), with weekend and holiday support. Shifts from either 0700-1600, 0800-1700 or 1030-1930.

Essential Duties & Responsibilities:

• Perform routine Environmental Monitoring (EM) of GMP-controlled areas
• Support Personnel Monitoring during Manufacturing Operations
• Perform testing on Microbiological samples (Bioburden, Endotoxin, sterility)
• 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
• Maintain inventory levels in QC labs 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 high hygiene standards required for cGMP cleanroom operations
• Other duties as assigned

Minimum Qualifications:

• Education/Training: High School Diploma or greater
• Experience: 1-2 years of relevant experience; prior work in a GMP facility is highly desirable
• Knowledge: Basic understanding of GMP regulations and cleanroom behavior Basic understanding of cGMP microbiology lab practices
• Familiarity with LIMS 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, bending, lifting and squatting required. Effective verbal and written communication skills Dependable with a strong work ethic
• Certifications/Licenses: None required

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.