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Coordinate and perform cGMP manufacturing operations for manufacturing biopharmaceutical products. Responsible for completing paperwork for each task, cleaning procedures, aseptic processing techniques, Good Manufacturing Practices (GMP) and laboratory safety practices and procedures.
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Experience Requirements: A minimum of 5 years of experience in a laboratory setting and work in a regulated cGMP Manufacturing environment (FDA, EPA, etc. Accountable for following Standard Operating Procedures (SOPs) and adhering to cGMP guidelines.
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Previous experience with Laboratory IT systems such as LIMs, LES, and MODA. Additional Preferences: Experience with cGMP requirements and regulatory compliance associated with a cGMP Manufacturing facility.
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You are expected to partner with members of other technical functions (e.g. Cell Line Development, Upstream Pharmaceutical Sciences, and Global Manufacturing Sciences, Global Quality, Regulatory, Supply Chain) to independently develop laboratory studies that are geared at improving cell banking operations which eliminate waste, improve efficiency, and improve process performance/robustness.
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Must also be familiar with AbbVie Quality Systems as well as cGMP and other regulatory requirements. Must be familiar with use of electronic document management and laboratory information management.
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NEEDED: Aseptic Process Validation Engineering / Packaging Engineering a MUST (boxes, cartons, bottles, labels, tamper bands); R&D Laboratory; Ocular Health/Pharmaceutical/Medical Device Products Packaging Industry; Design/Test/Assembly; Packaging Test Equipment Validation; IQ/OQ/PQ; SOPs; Report Writing; cGMP/GMP; FDA/NDA; 21 CFR Part 210/211.
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Quality Specialist III: A minimum of 4 years of professional experience working in a cGMP regulated environment, To Include: previous training experience and comprehensive understanding of laboratory production processes required.
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Monitor the training imparted on laboratory techniques, quality control procedures and principles of cGMP & GLP. II. Monitor the execution of all routine quality control operation and stability studies to ensure timely delivery and meet regulatory requirements and cGMP, GLP guidelines.
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Operation of laboratory instruments including automated chemistry modules, purification, and analytical instrumentation for radiopharmaceutical production. The RII operates a complete cGMP/GLP production facility to produce PET radiopharmaceuticals for human clinical and translational research.
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Must possess a sound knowledge of pharmaceutical cGMP regulations with emphasis on laboratory operations. Must possess knowledge of a wide range of laboratory instrumentation including, but not limited to, HPLC, GC, FTIR, autotitrators, etc.
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Conduct clinical research studies involving administration of investigational products according to the principles of current Good Clinical Practices (cGCP), Good Laboratory Practices (cGLP), and Good Manufacturing Practices (cGMP) and in accordance with all relevant host nation, US Federal, Department of Defense (DoD) and Army regulations and policies.
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The ideal candidate will function in a cutting-edge laboratory environment as part of a multi-disciplinary team of protein engineers, immunologists, molecular biologists, and protein biochemists to discover novel therapeutics with opportunity to develop cGMP or GLP compliant skills in an industrial laboratory setting.
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This position will develop and review protocols for new and existing cGMP systems, including manufacturing equipment, laboratory instrumentation, and processes, across our network of manufacturing facilities.
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The candidate for this position is required to maintain accurate and efficient laboratory records and ensure operations adhere to Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP.
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Lead, mentor and coach laboratory personnel on quality matters, including regular presence in the QC Laboratories areas to monitoring GMP programs and quality systems. Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance.
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