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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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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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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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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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A minimum of 1 year experience in cGMP, academic or lab setting with aseptic experience. Verification of intermediate process days which include expertise with the wave bioreactor, NC-200 and in process environmental monitoring.
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Batch record review, process streamline improvements, safety walk-throughs. Maintains and prepares equipment/environment for use, proficient in the use of production related IT systems such as SAP, LIMS and MES, documents all steps in the assigned Batch record in line with GMP requirements.
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A minimum of 1 year experience in cGMP or academic or lab setting with aseptic experience. Cell Processing Specialist I will also be responsible for the formulation and verification of all media lots.
$28.37 - $43.22 an hourFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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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.
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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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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.
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cgmp job in Montville, NJ
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