Microbiologist I (Pittman Schedule, 2-2-3 6p-6a)

Exela Pharma Sciences•Lenoir, NC

1d•Onsite

About The Position

The Microbiologist I will perform Microbiological laboratory testing associated with Environmental Monitoring (EM), Water for Injection (WFI), and product specific Microbiological samples. Additionally, the Microbiologist will be trained to perform Environmental Monitoring (EM) and Water for Injection (WFI) sampling in support of cGMP manufacturing activities associated with sterile manufacturing.

Requirements

Minimum of 1 year of related laboratory experience, academic or otherwise
Knowledge of aseptic techniques
Knowledge of cGMP
Experience in activities pertaining to aseptic manufacturing and knowledge of how to maintain an aseptic environment
Ability to multi-task, work under pressure with time constraints
Must be flexible and able to adapt to changes in task priority
Excellent communication skills and ability to work independently to complete tasks
Bachelor of Science (BS) Degree in Microbiology, Biology, or related Life Sciences.

Responsibilities

Perform bioburden testing for In-Process products and raw materials to assess potential microbiological contaminants.
Perform bioburden testing for Water for Injection (WFI), City Water, and Reverse Osmosis Water (RO) to assess potential microbiological contaminants.
Perform Endotoxin testing for In-Process products, Aseptic/Terminally Sterilized products, and Raw Materials.
Perform Total Organic Carbon (TOC), Conductivity, and Endotoxin testing on Water for Injection (WFI) and Clean Steam samples.
Perform sterility testing of Aseptic and Terminally Sterilized products.
Perform Microbiological Organism Identifications to the genus and species level.
Perform Growth Promotion/Quality Control Testing of Microbiological media and/or materials used for Microbiological sampling and testing.
Perform Biological Indicator testing to support Validation studies/qualifications.
Read plates generated from Environmental Monitoring and Microbiological Laboratory testing.
Operate an Autoclave to perform sterilization and decontamination cycles and equipment, media, and biohazard waste.
Perform daily and weekly laboratory cleaning requirements.
Disposal of hazardous waste and non-hazardous waste following applicable EHS training.
Perform sampling of Water for Injection (WFI), City Water, Reverse Osmosis Water (RO), and Clean Steam to support manufacturing and/or qualification activities.
Perform Personnel Monitoring of sterile garbed personnel.
Perform Compressed Air and Compressed Gas sampling to support manufacturing and/or qualification activities.
Perform Viable Air, Total Particulate Air (Non-Viable), Surface (RODAC), and Swab sampling to support manufacturing and/or qualification activities.
Perform Standard Operating Procedure (SOP) revisions.
Perform Microbiological Deviation Investigations, Corrective and Preventative Actions (CAPAs), and Change Requests (CRs).
Complete Resource Conservation and Recovery Act training within 6 months of hire and annually thereafter.