Associate Scientist, QC Microbiology
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Job Detail
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Job Description
The Associate Scientist, QC will oversee the end-to-end contamination control and sterility assurance practices for Catalent’s aseptic production process. This position will support the following areas: Aseptic processing, cleaning and disinfection process, microbiological testing, environmental control and monitoring, compliance to regulations and standard in the subject of sterility assurance and contamination control. The Associate Scientist, QC will work both independently and with the team to perform routine and non-routine microbiological testing and microbiology laboratory maintenance functions, where necessary.
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
Shift: Monday-Friday 12am-8:30am
The role:
- Ensure testing compliance meets the requirements of ISO, USP, CFT, cGMP, and GLP, in the Microbiology laboratory at all times.
- Document laboratory test results utilizing Good Documentation Practices.
- Conducts testing of utilities such as USP water, clean steam, and testing of other manufacturing environments (air, surfaces).
- Always maintain the Microlab in Audit Readiness.
- Provide accurate product, raw material, and Environmental monitoring microanalysis data
- Ensure daily or weekly maintenance of all Micro-laboratory instrumentation and media usage dates.
- Review Micro results for other Microbiologists, ensuring current results & report trends to the QC Manager.
- Perform Bacterial Endotoxin and Sterility Testing.
- Perform microbial identification via polymerase chain reaction (PCR).
- Perform growth promotion testing of microbiological media.
The candidate:
- Bachelor in a Microbiology, Molecular Biology, or related discipline with 0 – 2 years of experience working in a cGMP QC laboratory.
- Knowledge of cGMP, familiarity with Quality Tools such as SPC and Root Cause Analysis, USP, HACCP, and Technical writing skills.
- Test method development and validation of various bioassay and microbiological or chemical test attributes
- Demonstrate knowledge of scientific understanding of analytical and microbiological methods or chemical methods and their relation to natural processes.
- Demonstrated ability to investigate and identify causes of suspect laboratory results.
- Working knowledge of analytical and/or microbiological method design.