QC Microbiology Analyst 1
ProKidney
Summary
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.
Job description
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
- High School Diploma or greater
- 1–2 years of relevant experience; prior work in a GMP facility is highly desirable
- Basic understanding of GMP regulations and cleanroom behavior
- Basic understanding of cGMP microbiology lab practices
- Familiarity with LIMS is a plus
- 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
Requirements
- High School Diploma or greater
- 1–2 years of relevant experience
- Prior work in a GMP facility is highly desirable
- Basic understanding of GMP regulations and cleanroom behavior
- Basic understanding of cGMP microbiology lab practices
- Familiarity with LIMS is a plus
- 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
- Must be eligible to work in the United States without the need for work visa or residency sponsorship
Company overview
ProKidney is a clinical-stage biotechnology company pioneering innovative cell-based therapies for the treatment of chronic kidney disease (CKD). The company's proprietary platform technology, known as Renal Autologous Cell Therapy (REACT), aims to regenerate damaged kidney tissue and restore renal function in patients with advanced CKD. ProKidney's lead product candidate, REACT, is designed to be a minimally invasive, autologous cell therapy that utilizes a patient's own renal cells to promote tissue repair and regeneration. The company's approach represents a paradigm shift in nephrology, moving beyond symptom management to potentially address the underlying causes of kidney disease progression. With a focus on late-stage CKD patients who face limited treatment options and the prospect of dialysis or transplantation, ProKidney's technology holds promise for improving patient outcomes and quality of life. The company has advanced its clinical development program through multiple clinical trials and has established itself as a leader in the field of renal regenerative medicine.