Microbiologist I

Greiner•Monroe, NC

1d•Onsite

About The Position

This role involves carrying out microbiological testing and examination according to valid procedures, including Bioburden, Endotoxin, Sterility, Growth Promotion, cell growth (cell culture), and Environmental Monitoring. The position also supports method validations for OEM, Bioscience, and PreAnalytical products, and is responsible for the preparation of solutions and equipment for the microbiology department. Additionally, the role involves reviewing, editing, and drafting procedures, maintaining stock of consumables, and entering and trending microbiological data. The Microbiologist I will also perform validation testing for microbiological methods and sterilization, test non-conforming products, coordinate external sample testing, issue QIR/NCRs, and maintain the cleanliness and sanitation of the microbiology lab. Other duties as assigned.

Requirements

Minimum Bachelor’s Degree in a life science (preferably biology, microbiology, or related field).
Minimum one (1) year of relevant work experience in GMP-controlled laboratory environment.
Sufficient math, communication, and writing skills.
Must complete pre-employment examination and qualification test.
Knowledge of basic Microbiology, and USP and/or FDA guidelines.
Basic understanding of computer systems (Word, Excel, Outlook, and instrument dedicated).

Nice To Haves

Experience in Medical Device, Pharmaceutical, and/or regulated industry is preferred.

Responsibilities

Carry out Microbiological testing and examination according to valid procedures; such as Biobuden, Endotoxin, Sterility, Growth Promotion, cell growth (cell culture)and Environmental Monitoring.
Support to perform method validations for OEM, Bioscience and PreAnalytical products.
Preparation of solutions and equipment for microbiology department according to valid Test Procedures (TPs) and Standard Operating Procedures (SOPs) as required.
Review, edit, and draft of applicable TPs and SOPs.
Review and maintain stock of consumables (supplies and equipment) for Microbiology department.
Entry and trending of microbiological data for management review and trend evaluation.
Validation testing for microbiological methods and sterilization validation as needed.
Test non-conforming product to resolve QIR/NCR issues as well as investigate returned products via complaint processing system.
Coordination of sample testing via external/third-party vendor(s).
Issue QIR/NCR for non-conforming product and/or any lab test excursion and support to conduct root‑cause analysis as per standard procedure.
Cleaning and sanitation of microbiology lab.
Other duties as assigned.