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Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA principles of data integrity, risk-based approaches to validation, Computer Software Assurance (CSA) principles.
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1 years' relevant experience with materials management and/or supply planning within cGMP operations in matrixed organization with multi-level setup Strong organizational, analytical, and time management skills.
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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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1 year relevant experience with materials management and/or supply planning within cGMP operations in matrixed organization with multi-level setup. Joining a team of highly qualified materials management and supply chain professionals, this individual will be responsible for supporting the supply chain management process, systems, and software functions for MRP, ERP, data sources, testing, integrations, reporting, analytics, and more within the cell therapy network.
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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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Ideal candidates should have 2+ years of Document Control and report experience with at least 1 year being in cGMP/FDA regulated environment. Minimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment.
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Bachelor's degreeMinimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment. The Associate Specialist is responsible for activities in accordance with corporate policies, standards, procedures, and Global cGMP in support of the QA Disposition group.
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Extensive knowledge of cGMP requirements and regulations for pharmaceutical manufacturing. Come work for the leader in reproductive medicine and maternal health! Minimum 5 years engineering experience in a pharmaceutical industry setting with a focus on aseptic processing and lyophilization.
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O Provide cGMP and associated OJT training to any other quality members and other operational areas as needed. o Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed.
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2+ years of document control and reporting experience in cGMP/FDA regulated setting. Proficient in technical writing, MS Office, Document Management Systems, and Quality Management Systems; experience with Veeva Vault is preferred.
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Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
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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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Familiarity with aseptic techniques, cleanroom protocols, and cGMP is a plus. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our 'people first' philosophy.
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Responsible for Successful on time completion of required training curriculum comprising of the necessary Global Operating Procedures (GOPs), Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training including HSE for the specific role.
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cgmp job in Florham Park, NJ
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