EM Analyst (Contract) at ProKidney

Winston-Salem, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

23 Dec, 25

Salary

0.0

Posted On

24 Sep, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP Regulations, Environmental Monitoring, Microbiology Lab Practices, Documentation, Organizational Skills, Attention to Detail, Teamwork, Compliance, Microsoft Office, Communication Skills, Hand-Eye Coordination, Work Ethic

Industry

Biotechnology Research

Description

Position Summary: 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 ProKidney’s 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. 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: 1–3 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 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.

Responsibilities

The EM Analyst performs routine Environmental Monitoring of GMP-controlled areas and conducts Personnel Monitoring during Manufacturing Operations. This role involves setting up and operating EM equipment, following established procedures, and ensuring accurate documentation and reporting.