QC Microbiology Analyst I — GMP Lab Environmental Testing

Prokidney; Winston-Salem (NC); Sur place; USD 42 000 - 56 000; Plein temps

Résumé du poste

ProKidney is seeking a QC Microbiology Analyst I to support the QC Microbiology department. You will perform routine environmental monitoring, microbiological testing, and maintain strict cGMP documentation in a GMP environment.

The role requires collaboration with manufacturing and support teams and adherence to SOPs. Qualified candidates will have a High School diploma or higher, 1–2 years of relevant GMP experience, and proficiency with MS Office.

Qualifications

• High School diploma or higher.
• 1–2 years of relevant experience; GMP facility experience desirable.
• Basic GMP/cGMP microbiology knowledge and cleanroom behavior.

Responsabilités

• 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 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, and documentation updates.
• Maintain QC lab inventory and coordinate material requests with warehouse.
• Perform enumeration, gram staining, streaking and isolation of recovered organisms.
• Complete documentation accurately and timely.
• Maintain high hygiene standards for cleanroom operations.
• Other duties as assigned.

Connaissances

Environmental Monitoring

GMP awareness

SOPs documentation

Microsoft Office

Teamwork

Attention to detail

Lab safety

Communication

Physical stamina

Formation

High School Diploma or greater

Outils

LIMS

Description du poste

ProKidney is seeking a QC Microbiology Analyst I to support the QC Microbiology department. You will perform routine environmental monitoring, microbiological testing, and maintain strict cGMP documentation in a GMP environment.

The role requires collaboration with manufacturing and support teams and adherence to SOPs. Qualified candidates will have a High School diploma or higher, 1–2 years of relevant GMP experience, and proficiency with MS Office.