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Understand the expectations of audit readiness (OSHA, FDA, QSR, GMP, ISO, etc.) - Executes the process of assembly, filling, labeling & packaging equipment of varying complexity and in accordance with production manufacturing records, operating procedure requirements to produce finished intermediates, instruments, and final kits while meeting production targets.
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Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications. A minimum of four years' experience in biopharmaceutical manufacturing in a GMP environment.
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Job activities include the preparation of equipment and components for aseptic filling operations, performing visual inspection of filled vials, vial labeling, vial packaging and distribution of filled vials as per GMP regulations.
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The Manufacturing Technician is responsible for supporting the overall GMP Fill Finish manufacturing processes, through the application of broad knowledge of theories, techniques, and principles utilized to solve operational and routine tasks in the aseptic production of finished drug product biologics for commercial GMP manufacturing.
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Participate in production needs including bottling, filling, sealing, labeling, etc. Assist in the implement of GMP compliance documentation and record-keeping measures. Organize and maintain facility at GMP compliant level.
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Gmp, Assembly, Packing, Cleanroom, General production, Sop, Labelling, Packager, Packaging, Production, General labor, Packaging line, Pharmaceutical, Medical device, Assembly line, Fill, Manufacturing environment, Inspection, Filling, Cleaning, Troubleshooting, Detail.
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Performs manual or automated filling and packaging of blistered and bottled pharmaceutical products. Applies Good Manufacturing Principles (GMP) in all areas of responsibility, including following regulations and activities in a safe and efficient manner.
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The Associate Director, Biologics Quality Assurance will report to the Head Biologics Quality and will be part of a dedicated insulin team at our Petersburg, Virginia state of the art formulation and filling facility.
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The incumbent will provide Automation support to the daily operations, continuous improvement, and projects for the Pilot Plant, Bulk Manufacturing, Filling, Assembly, Packaging, Utilities, Facilities, and other DCS and PLC Automated Equipment and Control Systems on a GMP regulated environment.
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Work closely with colleagues in Process development to design and implement new technologies for aseptic filling of cell therapy drug products in novel device platforms; this includes working closely with Contract Development and Manufacturing Organizations (CDMOs) and engineering firms to design processes and equipment needed to perform aseptic filling operations in a GMP environment.
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Sterilization and aseptic filling validation. Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments. A minimum of 3 years of relevant experience in a GMP regulated environment.
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Our unique blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more.
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The organization consists of operational teams for Filling, Formulation, wash and sterilization, as well as inspection and support. External US About This Role The Associate Director for DPM is responsible for executing GMP readiness and preparing for the operation of the new facility to support customer onboarding.
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BioPharma, Pharma, Quality, ISO, FDA, QA, QC, CMO, Sterile Aseptic, filling, BFC, remediation. Experience in risk management, tech transfer, validation, analytics, and microbiology and/or chemistry, within a GMP environment.
Full-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Understands GMP, QSR, ISO and RMS quality regulations. Assists and monitors filling, labeling and packaging/warehouse equipment of varying complexity in accordance with SOPs, production batch records and filling records and packaging records.
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filling gmp jobs
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