Microbiology Analyst

Department: Microbiology

Location: Monroe, NC

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Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity) with eight molecules in various stages of clinical development. The company has a significant presence in branded generics markets across emerging economies including India. Its subsidiary, Glenmark Generics Limited has a fast growing and robust US generics business. The subsidiary also markets APIs to regulated and semi-regulated countries.

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.

  Education:

• Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or equivalent.

• Microbiology degree preferred

Experience:

• 1-3 years of experience in a cGMP/GLP laboratory.

• Pharmaceutical & FDA/GMP industry experience is preferred.

• Microbiology laboratory experience, such as aseptic techniques required.

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