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4) years experience performing test methods equivalency study and marketed product test method suitability gap closure according to cGMP. Leading departmental and/or company-wide projects designated to improve the nature of SGS client services; Assuming study director responsibilities for all routine microbiology studies as well as more advanced or specialized studies as requested by clients.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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It is each employee’s responsibility to perform their work properly and ensure a product or service meets the current Good Manufacturing Practice (cGMP) requirements for Safety, Identity, Strength, Purity, and Quality.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Work directly with other departments such as Production, Quality Control, Technical Support, and IT to advise and oversee the requirements for cGMP, sampling, qualification, statistical process control analysis, software qualification, transfer of production, and other activities related to the scope of the business are met on a continuing basis.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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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.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer. Experience in the qualification of cell therapy equipment a plus. The Equipment Validation Engineer supports the successful implementation of various process/lab.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support, and secondary packaging.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Experience with MES infrastructure, ALM and Veeva document/change management systems and middleware WebMethods. The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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On-Board Services is hiring a Validation Specialist in Summit, NJ! The Specialist will partner with site Business Owners, CI Owners, Quality, and the global EMES team to create, manage, and improve computerized systems/Recipes validation deliverables for electronic systems, applications, and associated controls to maintain data integrity supporting ALCOA+ principles throughout the CSV lifecycle.
$57.59 - $62.39 an hourFull-timeExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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Familiar with the development of CSV documentation (Validation Plans, Requirements, Design / Configuration Specifications, Test Scripts [IQ/OQ/PQ/UAT], Summary Reports, Trace Matrices, SOPs) Minimum of 2+ years relevant work experience required preferably in a pharmaceutical manufacturing environment.
ExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Primary Talent Partners is seeking a Manufacturing Systems Validation Engineer to join our large biopharmaceutical client in the Summit, NJ area. The Specialist will be responsible for ensuring the validation of the S12 Enterprise Manufacturing Execution System (EMES), and applications are done following the relevant Client procedures, such as CSV SOP but no limited and applicable health authority regulations.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE) and Recipe Authoring/Validation. Ability to work extended hours or a modified work schedule to assist manufacturing operations support model, including 12x7 on-call support rotation.
ExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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Operates and maintains laboratory equipment and instrumentation required for cGMP analysis of samples. Run instrumentation such as, but not limited to: ICP-MS, HPLC, GC, UV, IR, AA, DSC, KF on products according to compendial, client and internal methodologies.
ExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Seeking 1-2 years’ related experience with tissue manufacturing cGMP environment. Good understanding of clinical manufacturing operations in a cGMP environment. GxP regulation knowledge (cGTP, cGDP, cGMP.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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2+ years of document control and reporting experience in cGMP/FDA regulated setting. Piper Companies is currently seeking a QA Document Control Associate for an opportunity in Summit, New Jersey (NJ), to join a global biopharmaceutical company delivering life-saving medicines to patients with serious diseases.
$24 - $26 an hourFull-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Packing Operator is responsible for safely operating the package equipment to package in-process products in accordance with Packaging batch record while following SOPs and Maintaining 100% cGMP and compliance during operations.
ExpandApply NowActive JobUpdated 23 days ago
cgmp job in East Hanover, NJ
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