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OQuality targets; Manage Quality Systems to meet FDA / OTC, China NMPA, and Health Canada cGMP compliance. Performs as overall Operations leader for Melville 350 Manufacturing Plant and manages flagship complex operations in alignment with the Global and North American Supply Chain strategies and operating plans to deliver key factor results in Safety, Quality (cGMP requirements), Customer Service and all aspects of Plant Operating Costs across a $70MM + Operating budget and 700+ employees.
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Ensure compliance with all cGMP requirements, including batch record review. Ensures the work area is maintained in a clean an orderly manner in accordance with cGMP and internal requirements.
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Plant Operator Packaging Line operator Clinical supply operator Fix-its/Turnarounds Operations Management and Execution Operational and Design Safety zero incidents in Projects and in operations Compliance with cGMP, HSE Audits etc.
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Follow cGMP and corporate quality SOP’s at all times. Job: Manufacturing - Supply Chain Primary Location: US-NY-Melville Job Type: Standard Schedule: Full-time Shift: 2nd (Afternoon) Shift Job Number: 249677 We are an equal opportunity employer.
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Quality targets; Manage Quality Systems to meet FDA / OTC, China NMPA, and Health Canada cGMP compliance. Develop a culture and an environment through the PPS which executes effectively Lean Sigma, Continuous Improvement and Operational Excellence techniques that will deliver transformational and “best in class” results in the areas of Employee Relations, Safety, Quality, COGS, Customer Service and Plant Operating Costs.
$257,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Ensure compliance with cGMP requirements, including batch record review. The Manufacturing Night Shift Supervisor is responsible for overseeing the manufacturing of human plasma into protein intermediates, ensuring compliance with cGMP requirements and safety regulations while leading a team of technicians and operators.
$115,000 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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The QA Technical Affairs/Document Control Associate is responsible for supporting the Technical Affairs/Document group in the creation, review, revision, oversight, and maintenance of all master and controlled cGMP documents generated at the site and maintaining both their physical and electronic records (e.g. in ETQ, Formulator, and SAP systems) as per company procedures and policies.
$30 an hourFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Must be able to document process as per formula and SOPs and is responsible for following safety rules, SOPs and cGMP guidelines. education: No Degree Required. In this role, you will play a vital part in the dispensing of raw materials, adhering to our rigorous Standard Operating Procedures (SOPs) and Good Manufacturing Practices (cGMPs.
$42,000 a yearFull-timeExpandUpdated 29 days ago - UpvoteDownvoteShare Job
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Knowledgeable with the following: ultrafiltration and other filtration systems, cGMP facility design (cleanrooms, ISO classes, HVAC), utility systems common to the biopharmaceutical industry (e.g., WFI, RO water, compressed gases), clean-in-place (CIP) & (COP) equipment and cleaning cycles, clean room design, TCUs and operating principles.
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Applied Business Insights Digital & Technology Savvy Operational Excellence Project Excellence Manufacturing Process/Product Expertise Control Strategy and Process Performance Monitoring Knowledge of CAPA Technical Launch & Transfer Data analytics Quality Change Control.
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Cooperates with the other MS&T Key positions to manage technical activities Provides support to the MS&T key positions in the execution of their activities Applied Business Insights Digital & Technology Savvy Operational Excellence Project Excellence Manufacturing Process/Product Expertise Control Strategy and Process Performance Monitoring Knowledge of CAPA Technical Launch & Transfer Data analytics Quality Change Control.
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In addition, you will ensure quality of product in accordance with all NYBC’s Standard Operating Procedures, work instructions and regulatory standards, as well as following and practicing cGMP in all work.
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Understands and respects responsibilities of working in an SOP and cGMP environment. Interprets job ticket information and customer specifications in order to efficiently set-up and run bindery equipment.
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