Overview
Scientist, QC Microbiology Jobs in Harmans, Maryland, USA at Catalent
Location: Harmans
The 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 standards in the subject of sterility assurance and contamination control. The 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.
Shift: Thursday-Sunday- 8am-6:30pm
The role:
Ensure testing compliance meets the requirements of ISO, USP, CFT, cGMP, and GLP, in the Micro-laboratory at all times.
Document laboratory test results utilizing Good Documentation Practices.
Conduct 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.
Be the SME for all Micro-laboratory instrumentation.
Review Micro results for other Microbiologists, ensuring current results & report trends to the QC Manager.
Communicate effectively with QC peers, cross-functional peers and management.
Assist in troubleshooting and solving problems that may come up in the day to day operation of the department.
The candidate:
Bachelor in a Microbiology, Molecular Biology, or related discipline with 2 – 4 years of experience working in a cGMP QC laboratory.
Masters’ in a Microbiology, Molecular Biology, or related discipline with 0 – 2 years of experience working in a cGMP QC laboratory.
Experience working in cGMP Quality Control.
Experience in cGMP environment and experience 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 strong scientific understanding of analytical and microbiological methods or chemical methods and their relation to natural processes.
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.
Catalent is an Equal Opportunity Employer, including disability and veterans.
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Title: Scientist, QC Microbiology
Company: Catalent
Location: Harmans, Maryland, USA
Category: Quality Assurance – QA/QC, Healthcare (Data Scientist, Medical Science)
