• Microbiology Analyst

    Glenmark Pharmaceuticals Inc., USA (Monroe, NC)


    Microbiology Analyst

     

    Department: Microbiology

     

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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.

    POSITION SUMMARY :

    The Microbiology Analyst is responsible for performing microbiological tests that support the release of intermediates and finished products. These include routine and non-routine microbiological tests on in-process and final container products, as well as environmental monitoring samples. This position also contributes to the completion of regular routine technical tasks.

    JOB 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

    Knowledge and Skills :

    + Knowledge of current cGMP regulations for laboratory setting

    + Proficient in Windows, Microsoft Word, Excel.

    + Good written, verbal, and communication skills.

    + Good documentation skills.

    + Strong organizational skills.

     

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