QC Microbiology Analyst I — GMP Lab Growth & Impact

ProKidney; Fort Worth (TX); Presencial; USD 52.000 - 78.000; Jornada completa

Descripción de la vacante

ProKidney is seeking a QC Microbiology Analyst I to join its QC Microbiology department in Fort Worth, TX. You will perform routine environmental monitoring and microbiological testing, ensuring timely documentation and reporting in a GMP environment.

The role supports manufacturing operations with 5/8 shifts (Sun-Thu or Mon-Fri) and various start times. You will collaborate with cross-functional teams, adhere to SOPs and WI, and contribute to continuous improvement in lab operations.

Formación

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

Responsabilidades

• 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 SOPs, WIs, Protocols and safety requirements; document lab work per cGMP.
• Participate in revising and training on SOPs, WIs, Forms, and Protocols.
• Support lean initiatives in 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

Conocimientos

Environmental Monitoring

Documentation

Team collaboration

Attention to detail

Microsoft Office

Communication skills

Problem solving

Educación

High School Diploma or greater

Herramientas

LIMS

Visio

Excel

Descripción del empleo

ProKidney is seeking a QC Microbiology Analyst I to join its QC Microbiology department in Fort Worth, TX. You will perform routine environmental monitoring and microbiological testing, ensuring timely documentation and reporting in a GMP environment.

The role supports manufacturing operations with 5/8 shifts (Sun-Thu or Mon-Fri) and various start times. You will collaborate with cross-functional teams, adhere to SOPs and WI, and contribute to continuous improvement in lab operations.