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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.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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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.
Full-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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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.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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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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Provide cGMP and associated OJT training to QA and other departments to improve right the first time (RTFT) initiatives, high quality performance. Complete job-related training in electronic database system along with GMP, safety, and Ethics & Compliance course requirements.
Full-timeExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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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.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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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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Support manufacturing sites with process engineering and facility designs for strategic projects including development of User Requirements, technology evaluations, equipment selection, cGMP considerations and regulatory compliance.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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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.
ExpandApply NowActive JobUpdated 3 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 3 months ago - UpvoteDownvoteShare Job
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Complete Trackwise deviations and qualification / validation deviations related to equipment / instrument, cleaning, and process non-conformances, and assist Validation Specialist with same activities.
$61,750 - $143,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - 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.
Full-timeExpandApply NowActive JobUpdated 1 month ago
cgmp job in Fairfield, NJ
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