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The Quality Assurance Manager will ensure compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and exporting countries regulation as applicable (such as FDA, MHRA, EMA, Health Canada.
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Document all testing activities in accordance with cGMP.Performs duties according to LSS Global direction and in compliance with cGMP and GLP regulations and SGS Integrity programs. Job DescriptionThe Chemist I, Extractable & Leachable will perform material extractions, standard solution, and sample preparations to support GC-MS/FID and/or LC-MS/PDA and/or ICP-MS/OES analysis on extractable and leachable (E&L) testing of pharmaceutical containers and medical devices.
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Compiled standard operating procedures based on cGMP and HACCP requirements, and established the laboratory in functioning capacity. Host FDA inspections, and compile a set of standard operating procedures based on cGMP guidelines, and validated operating systems.
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Abides by all cGMP, FDA and DEA regulatory standards. Schedule:M-F Full Time. Supports master data coordinator, maintaining accurate planning master data (e.g. maintaining SAP material masters, BOMs, and recipes and mapping out cycle times), performing regular reviews, and modifying when necessary.
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5-7 years of cGMP environment, aseptic processing, mammalian cell culture, cell processing, cryopreservation experience. Deep understanding of cGMP and cGLP. Bachelor's degree (ie Biology, Biotechnology, Bioengineering, Chemical Engineering.
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Provide technical support for EMS during off business hours and participate in weekendtechnical support.d. Implement maintenance program and repairs including trouble shooting of equipment andsystem malfunctions, insuring compliance with current good manufacturing practices(cGMP.
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Knowledge of GCP and global cGMP regulations, (knowledge of EU GMP QP regulations is preferred), a plus. Knowledge of the operation and technical theory for the following analytical chemistry instruments: KF, FTIR, HPLC, GC, LC/MS, PSD, XRD, and DSC.
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Assist and support Associate Director in managing Contract Development and Research Organizations (CDMO) in the areas of Analytical Chemistry Method Development and Clinical Trial Material (CTM) manufacturing.
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Skills : Cell processing, clinical cell therapy, gene therapy, biologics. Meet client process demands through planning, scheduling, manufacture and delivery of clinical cell therapy products according to established procedures, regulations and contract.
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Familiarity of industry standards such as cGMP, IQ/OQ, ASME, UL/CE, BPE, FDA). 6 to 7+ years of experience in industrial capital equipment sales. Support, train, coach, and motivate CPS staff & DCI sales team personnel.
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The Manufacturing Operator/Technician II is responsible for all functions relating to the processing of drug products; consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOP.
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Resolve observation / CAPAs generated from internal and external cGMP audits related to Validation, Qualification, and Commissioning studies. Understanding of validation principles, current Good Manufacturing Practices (cGMP), and applicable regulatory requirements.
$61,750 - $143,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Partner with DCI to create sales strategies and successful proposals for current and prospective customers within the assigned territory. Support the lead generation, quotation, negotiation, and closing of sales for major customers, engineering firms and/or other equipment manufacturers/suppliers.
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Analyzes inventory levels and MRP exception messages in relation to updated forecast and order requirements and formulates response plans to ensure the company"s production and sales goals are met, customer order fulfillment is completed on time, and any material concerns are addressed.
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I will abide by all cGMP, FDA and DEA regulatory standards. Serves as backup to Purchasing Specialist and is able to handle additional projects and assignments as required, including the proper filing of purchase orders.
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cgmp job in Totowa, NJ
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