Purolite is hiring a Senior QC Microbiologist for our new manufacturing facility in King of Prussia, PAwho will demonstrates use and application of standard microbiology, project management, and other relevant principles, theories, concepts and techniques to assignments where precedents may exist. Provides solutions to a variety of problems which require collecting and analyzing data from diverse sources to solve problems. Demonstrates initiative and open mindedness to identify and try the new and different approaches.
What You Will Do:
- Understanding the differences between USP 61 and USP 62.
- Microbiologist with understanding of the difference between high nutrient and Low nutrient broth such as R2A.
- Knowledge of the objectionable organisms.
- Knowledge about grades of waters and each grades requirements through testing.
- Establishment of Environmental and utility monitoring programs.
Responsibilities:
- Cleanroom experience and oversee gowning qualification program.
- In charge with the Microbiology operation, ensuring EM sampling, laboratory processes will provide high quality analytical support for manufacturing, engineering and validation operations while ensuring compliance of protocols, GMPs, and safety regulations.
- Provides broad-based QC Microbiology hands on expertise.
- Review and approve Bioburden, B&F, and Sterility testing reports.
- Oversee and manage the contract laboratories.
- Support Regulatory audits.
Qualifications:
- BS/MS in Chemistry, Biochemistry, Microbiology, Pharmacy or related science degree.
- 3 years' experience in a GMP pharmaceutical environment with a strong working knowledge of quality systems.
- 3 years of aseptic and sterile manufacturing experience.
- CAPA and root cause, internal audit expertise in a QC microbiology laboratory in the pharmaceutical industry.
- Experience with Microbiology and Environmental Monitoring is required.
- Product and Water Sampling experience in a Clean Room environment required.
- Shift and weekend work required as per business needs (Floater Role).
Benefits
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