What are the responsibilities and job description for the Senior Microbiology Analyst position at Glenmark Pharmaceuticals?
Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules – both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA is a fast growing and robust US generics business, with plans to move into the innovative market as well. The USA subsidiary also markets APIs to regulated and semi-regulated countries.
Position Summary
Position Summary
- The Senior Analyst, Quality Control Microbiology is responsible for performing microbiological tests that support the release of intermediates and finished products. These include routine and non-routine microbiological tests and investigative testing 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 and participate in method and instrument qualification.
- Take appropriate steps to reduce wastages and losses in the Microbiology department
- Limit outsourcing of microbiology testing to contract laboratory.
- Perform sterility testing on raw materials, finished products and stability study samples.
- Perform Microbial Enumeration Test, Specified Organism Test, Bacterial Endotoxin, Bioburden, Liquid Particulate Counts test, Growth Promotion, Subculture, gram Staining Biological Indicator testing.
- Maintain accurate and complete test records.
- Help maintain inventory by reporting needed supplies.
- Maintain sample logs on a daily basis to ensure timely testing and tracking of all samples.
- 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.
- Responsible for ensuring compliance to systems and procedures in the Microbiology laboratory. And prepared the lab for internal and external audits.
- 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 (OOS).
- 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/PQ 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.
- Ensure that all equipment is calibrated.
- Responsible to develop and validate new test procedures
- Perform data analysis, compile data and generate reports for management review.
- Review lab test data and their integrity and adherence to SOPs and cGMP.
- Minimum BS/BA in Pharmaceutical Sciences, Biology, Biotechnology or equivalent.
- Microbiology degree preferred.
- 2-4 years’ relevant experience in a pharmaceutical/Biotech industry.
- cGMP/GLP laboratory / FDA industry experience is preferred.
- Microbiology laboratory experience, such as aseptic techniques required.
- 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.