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Maintain compliance with SOP, current Good Manufacturing Procedures (cGMP) and regulatory guidelines. Maintain compliance with SOP, current Good Manufacturing Procedures (cGMP) and regulatory guidelines.
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Lead Root Cause Failure Analysis (RCFA) and Failure Mode Effect Analysis (FMEA) in cGMP, biotechnology environment. Understanding of process improvement and reliability engineering principles, methodologies and tools such as PDCA, LEAN, Six Sigma / DMAIC, FMEA is desirable.
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Overview of this Position:The responsibilities of the Manufacturing Supervisor include, but are not limited to, the ability to Manage routine manufacturing tasks adhering to the guidelines of established procedures and cGMP regulations under direction of management.
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With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. There are so many ways Octapharma Plasma can enhance your life and your career.
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Selection of suitable plasmapheresis donors by performing physical examinations and taking medical histories on all donors through the use of FDA approved Standard Operating Procedure (SOP) Manual, current State and Federal guidelines, OSHA, CLIA, CGMP, all internal company procedures and personal education and experience.
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Knowledge of cGMP for pharmaceutical and/or vaccine manufacturing, Lean Six Sigma Methodology, Root Cause Analysis, Failure Mode Effects Analysis, knowledge in reliability engineering (including asset life cycle management.
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Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. Regulated Responsibilities (including cGMP and EHS.
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And if you know someone else who'd be a great fit at Octapharma Plasma, Inc., please forward this posting along! More About Octapharma Plasma Inc. Our strong growth is creating great learning and career development opportunities throughout our company, and especially our donation centers.
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A minimum of five years' experience in a cGMP facility, including experience with Continuous Improvement and Project Management. Strong problem solving and applied statistics skills are requiredCertification in Lean manufacturingSix Sigma certification ' green/black beltExpert in CAD / SPC / Gantt ChartsERP experience is a plus, preferably design, testing, and implementation related to manufacturing processesSelf-motivated worker with the ability to identify priorities and work independently.
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Perform calibrations in cGMP, cGLP, Non-GMP, and ESD environments. Work on systems including autoclaves, bioreactors, UF skids, Chromatography, CIP, WFI, and RODI.- Calibrate balances, scales, pH and conductivity analyzers, liquid and gas flow meters, levels, temperature and pressure transmitters, VCD & DO analyzers, CO2, and RH controllers.
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A Minimum of 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
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Demonstrated work experience in compliance with cGMP and FDA requirements, including Good Documentation Practices (GDP). This position is for a major pharmaceutical company , and this position is a suitable for someone with an associate or bachelor’s degree, with 2-5 years of experience in calibration, maintenance, repair, and performance verification work.
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Support cGMP manufacturing and technology transfer to our internal manufacturing facilities and external contract manufacturers. Doctorate degree in organic chemistry or biochemistry with a specialization in biocatalysis, oligonucleotide chemistry, synthetic/conjugation chemistry and/or chemoinformatics/machine learning.
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Transport full pallets of finished goods to storage and staging areas with power and pallet jacks in a timely manner, observing all safety regulations and ensuring all cGMP and quality standards are met.
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Experience should include management of lab activities, technical support of a cGMP manufacturing facility, including strong knowledge and engineering leadership for viral vector manufacturing and processing equipment, and process characterization.
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