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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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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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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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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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Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. Experience in the qualification of cell therapy equipment a plus.
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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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Please only local candidates to Summit NJ. Must have relevant experience with materials management and/or supply chain within cGMP operations. Proficiency in ERP systems (I.e., Oracle, SAP, QAD.
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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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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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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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The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client Cell Therapy Above-site organization, including the document approvals, document change control process, periodic review and system reporting.
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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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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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Work on the design and development of experimental protocols, SOPs, etc., consistent with cGMP/GLP.Conduct all quality QC chemical tests for release of batches for patient use. Quality Control Radiopharmaceutical TechnicianAbout EvergreenEvergreen Theragnostics, Inc. is a radiopharmaceutical company based in Springfield, NJ. We operate in a brand-new state-of-the-art facility, focusing on CDMO services as well as commercialization of our own portfolio radiopharmaceutical products.
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cgmp job in Madison, NJ
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