QC Microbiologist
About The Position
The QC Microbiologist I will ensure contamination control of manufacturing facilities at RTP by performing environmental and water sampling and testing per USP and EP requirements where applicable. The QC Microbiologist I will ensure the timely and accurate testing of materials while maintaining and ensuring quality and compliance so as to meet the demands of production and other departments. Support of all manufacturing operations; including but not limited to process validation, environmental monitoring, and utility systems sampling and testing Perform environmental, water, and other utility sampling procedures Perform in-house microbiological assays Evaluate microbiological results including microbial identification, as needed Prepare timely analytical lab reports or summaries as required Perform Environmental and utility out of specification (OOS) investigations as needed Operate the Autoclave to ensure a supply of sterile testing materials Ensure the supply of laboratory testing materials is readily available Schedule, and coordinate shipping of samples for required testing to contract laboratories Troubleshoot instrument problems and work with the lab manager and equipment manufacturer's technical services to resolve issues in a timely fashion. Perform instrument maintenance and calibration verification/standardization as required by following company SOPs
Requirements
- Working knowledge and understanding of cGMPs, USP, EP and other regulatory requirements with respect to microbiology activities
- Proficiency in viable and non-viable environmental monitoring of manufacturing suites; gram staining, sub-culturing of microbial isolates, bioburden testing, gowning, aseptic technique
- Ability to work as part of a team and also independently with minimal to no supervision
- Computer application skills required with expertise in Microsoft office
Nice To Haves
- Bachelor’s Degree in microbiology, biology, or biochemistry or other related discipline
- 2+ years of relevant experience in a microbiology laboratory and with aseptic processing is preferred.
- Familiarity with Trackwise, MasterControl and LIMS
- Pharmaceutical GMP experience
Responsibilities
- Support of all manufacturing operations; including but not limited to process validation, environmental monitoring, and utility systems sampling and testing
- Perform environmental, water, and other utility sampling procedures
- Perform in-house microbiological assays
- Evaluate microbiological results including microbial identification, as needed
- Prepare timely analytical lab reports or summaries as required
- Perform Environmental and utility out of specification (OOS) investigations as needed
- Operate the Autoclave to ensure a supply of sterile testing materials
- Ensure the supply of laboratory testing materials is readily available
- Schedule, and coordinate shipping of samples for required testing to contract laboratories
- Troubleshoot instrument problems and work with the lab manager and equipment manufacturer's technical services to resolve issues in a timely fashion. Perform instrument maintenance and calibration verification/standardization as required by following company SOPs
Benefits
- medical / dental / vision / prescription coverage
- employee wellness resources
- savings plans (401k and ESPP)
- paid time off & paid parental leave benefits
- disability benefits
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
