Microbiology Analyst Department: Microbiology Location: Monroe, NC START YOUR APPLICATION (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req\_id=3155199&source=3155199-CJB-0) 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. START YOUR APPLICATION (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req\_id=3155199&source=3155199-CJB-0)