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ClinLab Staffing
Monroe, NC, United States
Microbiology Manager Monroe, NC Full-Time, Permanent Overview The Microbiology Manager reports to the Associate Director / Director, Microbiology. The primary responsibilities are to manage and coordinate staff performing microbiological testing, support the manufacturing of aseptically process and terminally sterilized pharmaceutical products. Pr
Job Source: ClinLab StaffingClinLab Staffing
Monroe, NC, United States
Microbiology Manager Monroe, NC Full-Time, Permanent Overview The Microbiology Manager reports to the Associate Director / Director, Microbiology. The primary responsibilities are to manage and coordinate staff performing microbiological testing, support the manufacturing of aseptically process and terminally sterilized pharmaceutical products. Pro
Job Source: ClinLab StaffingGlenmark Pharmaceuticals Inc., USA
Monroe, NC, United States
Location field must contain 'city, state' or a zip code to perform a radius search (e.g., Denver, CO or 46122 ). City and state must be separated by a comma followed by a space (e.g., Houston, TX ) Glenmark Pharmaceuticals Inc., USA Associate Director Microbiology in Monroe , North Carolina Associate Director Microbiology Department
Job Source: Glenmark Pharmaceuticals Inc., USAGlenmark Pharmaceuticals Inc.
Monroe, NC, United States
The QC Associate Director(AD), Microbiology manages a team of microbiologists to oversee all microbiological quality aspects of pharmaceutical manufacturing (injectable and OSD), including, but not limited to: sterility, environmental monitoring of warehouse, dispensing area, manufacturing, packaging, quality control, utility monitoring and site co
Job Source: Glenmark Pharmaceuticals Inc.Advantage Solutions
Matthews
**Summary** **Schematic Analyst** Are you looking to join a team for a fast-growing company that can offer you flexible scheduling, competitive rates, and the possibility for advancement as you move throughout your career? If so, SAS Retail Services has a great opportunity for you! As an SAS team member, you will partner with retailers to enhance t
Job Source: Advantage SolutionsGlenmark Pharmaceuticals Inc., USA
Monroe, NC, United States
Senior IT Associate Department: IT Location: Monroe, NC START YOUR APPLICATION (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req_id=3048620&source=3048620-CJB-0) Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules - both New Chemical Entities
Job Source: Glenmark Pharmaceuticals Inc., USAGlenmark Pharmaceuticals Inc., USA
Monroe, NC, United States
START YOUR APPLICATION (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req_id=3048620&source=3048620-CJB-0) 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 mole
Job Source: Glenmark Pharmaceuticals Inc., USAGlenmark Pharmaceuticals Inc.
Monroe, NC, United States
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 bu
Job Source: Glenmark Pharmaceuticals Inc.Monroe
Senior Microbiology Analyst
Department: Microbiology
Location: Monroe, NC
START YOUR APPLICATION (rmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req\_id=3117119&source=3117119-CJB-0)
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:
+ 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.
JOB RESPONSIBILITIES :
+ 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.
Education:
+ Minimum BS/BA in Pharmaceutical Sciences, Biology, Biotechnology or equivalent.
+ Microbiology degree preferred.
Experience :
+ 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.
START YOUR APPLICATION (rmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req\_id=3117119&source=3117119-CJB-0)
Email Alert for Senior Microbiology Analyst_ jobs in Monroe
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