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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. Pro
Job Source: ClinLab StaffingGlenmark Pharmaceuticals Inc., USA
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
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.Glenmark Pharmaceuticals Inc., USA
Monroe
Batch Release Reviewer Department: Batch Release Location: Monroe, NC START YOUR APPLICATION (rmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req\_id=3097309&source=3097309-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
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Job Source: CarowindsCulvers Restaurant
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Job Source: Culvers Restaurantati
Monroe, NC, United States
Position : Communications Manager Location : Monroe, NC Requisition ID: : 24-2237 Proven to Perform. From the edges of space to the bottoms of ocean, our materials are proven to perform -- and so is our team. We're hiring high performers as proven as our products. Join us. ATI is seeking a Communications Manager to help tell the story of ho
Job Source: atiMonroe, 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. Provides technical leadership, daily oversight and subject matter expertise as needed to manage the QC microbiology laboratory functions:
Reading, review and trend analysis of environmental monitoring and water test data
Contamination Control Strategy, Media Fills, Qualification for sterilizers
Developing and validating microbial test methods for bioburden, sterility, liquid particle counts and endotoxin test
Microbiological testing of raw-materials, in-process materials and finished products
In this role you will be the primary contact for the microbiology laboratory, collaborating with personnel outside of the department, facilitating timely and right the first time data management and reporting and assuring testing is completed in support of manufacturing timelines and regulatory standards.
Responsibilities
Operational Excellence (40%)
Ensuring compliance to system and procedures in the department and documentation.
Preparation of the Microbiology Laboratory for internal and external audits.
Ensure online documentation in microbiology laboratory.
Ensure compliance, revision and updates to SOPs as per Good Microbiology Laboratory practices and pharmacopeia.
Updating specification and standard test procedures of the microbiology section.
Work distribution to subordinates of Microbiology Section.
Procure consumables and other materials.
Ensure annual maintenance contact renewal (if any), calibration of laboratory instruments.
Prepare risk assessment in for various processes in microbiology laboratory.
Providing support for procurement and qualification of new equipment required in microbiology laboratory.
Ensure timely sampling, analysis and release of environmental, water samples.
Ensure timely analysis and release of Raw material, finish products and packing materials.
Ensure 100% training of subordinates in microbiology department as per the job requirement.
Review of change control, incidents, protocols and deviation of other departments related to microbiology.
Ensure requalification and calibration of instruments in micro lab as per the schedule.
Response preparation for internal and external audit observation. Implementation of CAPA in micro lab.
Review of regulatory audit observations at other sites and ensure compliance in microbiology department of the site.
To interact with site QA and inform about failures/ OOS / OOT / incident / Non compliances.
Stakeholder (40%)
Responsible for management of Microbiology department
Responsible for coordination with Production / R&D/QA/QC for various activities related to microbiology
Interact with different departments in case of OOT and OOS observations related to microbiology
Train and implement cGMP practices related to microbiology at all the manufacturing and related departments
Innovation (15%)
Training of manufacturing staff w.r.t. aseptic practices and microbiological staff
Financial (5%)
Providing support in Revenue and Capex Budget as per spent analysis project. Ensure financial prudence in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site.
Maintain quality system controls to ensure no critical and major market complaints.
Ensure that all statutory and regulatory compliance are regularly monitored and is in a state of compliance as applicable.
Take appropriate steps to reduce wastages and losses in the analysis process and build improved efficiency
Education and Experience
Bachelor degree in Pharmaceutical Sciences, Microbiology or equivalent required. Master’s degree in microbiology or equivalent, preferred
At least 5 years in the field of Pharmaceutical (formulation facility).
Background of functions of Microbiology.
Experience of working with Injectable facility.
Experience working with Audits
Knowledge of cGMP, validations and qualifications, regulatory guidelines, US Pharmacopoeias, Internal auditing, handling of regulatory inspections, well acquainted with QMS, well versed with change control/deviations and market complaint management system
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Email Alert for Microbiology Manager jobs in Monroe, NC, United States
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