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May serve as study director, principal investigator, or project leader for GLP and CGMP studies. The Principal Scientist is an advanced position, involved in planning own work and supervising day-to-day activities in the laboratory working under prescribed procedures (protocols, standard operating procedures, methods, etc.
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Write, review and implement SOP’s to ensure compliance with current Client standard and current Good Manufacturing Practices (cGMP) Knowledge of compendial and cGMP requirements, FDA regulations and the ability to interpret and apply them Proficiency with the use of global systems (e.g., Systems, Applications and Products (SAP), Document Control and Archiving (DCA.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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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.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Carry out all duties in accordance with Good Manufacturing practices (cGMP) and standard operations procedures. Create, revise, and maintain documents such as change controls, standard operating procedures, and qualification protocols.
$33.65 - $38.47ExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Carry out all duties in accordance with Good Manufacturing practices (cGMP), Safety protocols and standard operations procedures. Reporting to the Head of Operations, the Investigation Specialist will lead investigation process and equipment upsets through root cause problem solving methodologies, develop project plans to correct and implement solutions, and drive efficiencies initiatives within operations.
Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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The Warehouse Operator performs all functions relating to the receipt, dispensing, and storage of raw materials, finished products, and packaging materials; consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOPs.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Manufactures human blood-derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.
Full-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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Operate equipment in accordance to Safety, Quality, cGMP and Standard Work guidelines. Knowledge of basic Lean principles and tools including 5S, Standard Work and AM Steps 1-3. Actively eliminate Lean (8 forms) waste; develop standard work instructions and OPLs as required.
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Must Haves: cGMP/SOP's, Mechanical, Electrical, PM's The Maintenance mechanic will be responsible for maintaining manufacturing, filling equipment, facilities and utilities following Standard Operating Procedure.
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Learn and maintain thorough familiarity and compliance with all state and federal regulations, Standard Operating Procedure Manual, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP), and internal Company Procedures.
Full-timeExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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Responsible for performing sampling, routine and specialized testing of raw materials in compliance with Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs). Performs routine and specialized raw material testing according to Standard Operating Procedures and Pharmacopeia methods, in compliance with cGMP.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Under supervision, performs quality inspections to identify and remove sub-standard quality softgels and foreign materials from product lots according to Standard Operating Procedures and applying current Good Manufacturing Practices (cGMP.
ExpandApply NowActive JobUpdated 25 days ago - UpvoteDownvoteShare Job
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Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Knowledge of cGMP requirements and ISO standards. This position is responsible for all stages of receiving customer complaint, interacts with customer for additional information, acting as a liaison with plant QA, TCS, Sales, Order Fulfilment, Data Governance, and other areas necessary to satisfy customer’s expectations.
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The Product Specialist is responsible for sampling, testing, and storage of plasma collected from donors. Ensure all products and samples are moved to the proper storage unit, and the freezer is organized in a manner that allows for the appropriate segregation of units and quick location of products or samples.
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Lean, Six Sigma and cGMP experience preferred. Write, review or Approve Standard Operating Procedures, and internal investigations, as applicable. Competency in drug product batch record review and management and tracking of Quality Metrics.
Full-timeExpandApply NowActive JobUpdated 18 days ago
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