QC Microbiology Analyst I Contractor
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
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.