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Glenmark Pharmaceuticals · 4 hours ago

Microbiology Analyst

Monroe, NC

Full-time

Onsite

Entry Level

1+ years exp

Glenmark Pharmaceuticals is a leading player in the discovery of new molecules with a significant presence in the generics markets. The Microbiology Analyst is responsible for performing microbiological tests that support the release of intermediates and finished products, including routine and non-routine microbiological tests and environmental monitoring.

BiotechnologyHealth CarePharmaceutical

No H1B

Responsibilities

Help maintain inventory by reporting needed supplies. Take appropriate steps to reduce wastages and losses in the Microbiology department

Monitoring samples, in-process product samples, raw materials, and environmental monitoring (EM) samples

Successfully complete a gown qualification program to enter and work inside the aseptic manufacturing area

Perform critical manufacturing process interventions for viable and non-viable EM

Maintain sample logs on a daily basis to ensure timely testing and tracking of all samples

Perform routine sampling of critical process utilities (e.g., Water-for-Injection, Purified Water, Clean Compressed Air, Nitrogen Distribution System, etc.)

Count colony forming units (CFU) on Petri plates

Perform sterility testing on final products and raw materials

Perform Growth Promotion and Biological Indicator testing

Perform preparation of reagents, materials, and equipment used in microbiological testing in sterile environments, such as HEPA hoods

Maintain accurate and complete test records

Enter test results in the Laboratory Information Management Systems (LIMS)

Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples

Maintain current knowledge of regulatory and industry standards, trends and advancements

Other duties as identified by direct supervisor

Preparation, review and approval of sampling matrix and hold time schedule Conducts and communicates results of lab investigations when test results fall outside pre-established specifications and/or limits (OOS/OOL)

Performs routine equipment maintenance

Performs maintenance of spare parts inventory, calibrations and supervises third party maintenance and repair when necessary

Establishes good working relation with contract laboratories

Supports in the development of methods transfer and validation, troubleshooting, cross validation, IQ/OQ protocols

Supports activities regarding audits of suppliers and contract labs in support of vendor certification program

Conducts statistical evaluation of the manufacturing and inspection process and training QC staff

Assures laboratory databases are maintained and accurate

Ensures control of laboratory documentation (Raw Material COA, testing instructions, testing

Ensure that all equipment is calibrated

Qualification

Microbiology laboratory experienceCGMP regulations knowledgeAseptic techniquesLaboratory Information Management Systems (LIMS)Statistical evaluationWindows proficiencyMicrosoft Word proficiencyMicrosoft Excel proficiencyCommunication skillsDocumentation skillsOrganizational skills