What are the responsibilities and job description for the Microbiology Analyst position at Glenmark Pharmaceuticals?
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
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.
- Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or equivalent.
- Microbiology degree preferred
- 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.