QC Microbiology Analyst 1

The role

The QC Microbiology Analyst I supports the QC Microbiology department by performing routine environmental monitoring and microbiological testing. This role involves collecting and testing environmental and utility samples while working closely with manufacturing and support operations.

What you will do

• 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
• 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

Required qualifications

• High School Diploma or greater
• 1–2 years of relevant experience
• Basic understanding of GMP regulations and cleanroom behavior
• Basic understanding of cGMP microbiology lab practices
• 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

Nice to have

• prior work in a GMP facility is highly desirable
• Familiarity with LIMS is a plus

Before you apply

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

About the company

ProKidney develops therapies to treat Chronic Kidney Disease (CKD) using a patient's own cells.