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Performs independent technical review of documentation including Batch Production Records during and post-execution of cGMP activities. Oversees execution of remediation/CAPA activities required to continue production or move a process along.
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2+ years experience in a cGMP pharmaceutical/biotechnology laboratory. Plan and coordinate the activities required as part of the validation protocol with the departments of Production, Maintenance, Quality, Engineering and Stability.
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Production of blood component lots through cell culture, harvest, and cryopreservation. Experience within cGMP/FDA regulated industry. Adhere to the production schedule ensuring on-time, internal production logistics.
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Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements. Responsible for completing production batches and corresponding documentation, AQL inspections, reworks, and material reconciliation.
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The company focuses on producing cell culture products, instruments, and solutions that help customers streamline their discovery, development, and production processes, and by making custom cGMP bioprocess liquids that radically simplify customers' manufacturing workflows - regardless of batch size.
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Manufacturing Production Operator (Pharmaceutical Technician) Position SummaryCatalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide.
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Previous related work experience in a pharmaceutical production environment, including knowledge of related cGMP requirements and procedures is preferred. Work with the Line Supervisor to ensure all commodities for the scheduled production runs are transferred to the proper staging area.
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Demonstrated mechanical and technical knowledge of cGMP and pharmaceutical packaging standard operating procedures. The Packaging Tech II - 1st shift (Mon-Thurs, 5:00 AM to 3:15 PM), is responsible for demonstrated expertise on one or multiple production lines and to ensure safe, quality pharmaceutical product packaging.
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Manage production planning and resource allocation to ensure on-time delivery. Supervise production operators to ensure the safe and compliant synthesis and/or cellular extraction of commercial oligonucleotides.
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Manufacturing cGMP production activities include solution preparation, master/working cell bank production, upstream cell culture, downstream protein purification, mRNA and molecular therapeutics production, and small-scale fill/finish.
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The Senior Quality Assurance Specialist (Engineer) ensures compliant manufacturing procedures, equipment, and facilities in our new manufacturing facility in adherence with cGMP requirements, Quality Standards, and other regulatory requirements.
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The Production Associate, Pouch is an Hourly Non-Exempt position which contributes to our mission of saving and sustaining lives by inspecting, over-pouching, and performing quality checks on filled bags which hold IV therapies, premixed drugs, renal therapies, and other sterile solutions.
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Transfers and Introduces technology of cell therapy-based and therapeutic protein processes into manufacturing collaborating extensively with Scorpion’s Process Development group to develop cGMP-compliant, clinical-scale production processes.
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Is a boutique biologics CDMO providing cGMP manufacturing, bioanalytical, and process development services for protein modalities. The Microbiology Manager is also responsible for the development, implementation, and compliance of activities in the microbiology laboratory area to meet production goals, quality, and cost objectives.
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Assists PET nuclear pharmacists and radiochemists in all aspects of the day to day operation of the PET Production Facility and radiopharmaceutical production facility operating under cGMP, including radiochemical production area, analytical laboratory and clean room.
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