ProKidney

Develops cell therapy to treat CKD

QC Microbiology Analyst 1

Regulatory & Quality (Life Sciences)Posted on Nov 10

Full-timeWinston-Salem, NC, USANo salary listed

About the Job

Requirements

A high school diploma or greater is required.
One to two years of relevant experience is required.
A basic understanding of GMP regulations and cleanroom behavior is required.
A basic understanding of cGMP microbiology laboratory practices is required.
The ability to read and follow schedules and instructions is required.
Proficiency in Microsoft Office, including Excel, Word, and Visio, is required.
The ability to lift up to 30 pounds and to bend, lift, and squat is required.
The role requires eligibility to work in the United States without the need for work visa or residency sponsorship.

Responsibilities

Perform routine environmental monitoring of GMP-controlled areas.
Support personnel monitoring during manufacturing operations.
Perform microbiological testing on samples, including bioburden, endotoxin, and sterility testing.
Follow standard operating procedures, work instructions, protocols, and safety requirements, and document laboratory work consistent with cGMP requirements.
Participate in revising and training others on standard operating procedures, work instructions, forms, and protocols.
Support lean initiatives in laboratory operations, standard work, test method execution, documentation updates, and equipment qualification.
Maintain inventory levels in QC laboratories 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.
Provide weekend and holiday support as required.

Desired Qualifications

Prior work in a GMP facility is highly desirable.
Familiarity with a laboratory information management system (LIMS) is a plus.

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.

About the Company

ProKidney

Develops cell therapy to treat CKD

ProKidney develops rilparencel, a cell therapy designed to preserve kidney function in patients with advanced chronic kidney disease (CKD). The product is in late-stage clinical trials, and the goal is to delay or potentially avoid the need for dialysis by slowing the loss of kidney function. The treatment works by using transplanted or administered cells to support kidney tissue and function, offering a therapeutic option beyond standard care. ProKidney plans to commercialize rilparencel through sales to healthcare providers and direct-to-patient access, with potential partnerships with providers and insurers to expand access. The company differentiates itself by pursuing a first-in-class cell therapy specifically for CKD and focusing on a large, underserved patient population in the United States. Its mission is to transform CKD care by providing a treatment that preserves kidney function and reduces the burden of dialysis for millions of patients.

Company size: 201-500
Company stage: IPO
Headquarters: Winston-Salem, NC
Founded: 2015

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