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Under supervision, performs quality inspections to identify and remove sub-standard quality soft gels and foreign materials from product lots according to Standard Operating Procedures and applying current Good Manufacturing Practices (cGMP.
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Direct key personnel in donor selection, plasma collection and all manufacturing records to maintain the highest production standards in accordance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP.
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Job DescriptionThe Chemist I, Extractable & Leachable will perform material extractions, standard solution, and sample preparations to support GC-MS/FID and/or LC-MS/PDA and/or ICP-MS/OES analysis on extractable and leachable (E&L) testing of pharmaceutical containers and medical devices.
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Ability to perform complex data review of reportsNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS N/ARelocation support availableWork Location Assignment: FlexibleThe annual base salary for this position ranges from $99,900.00 to $166,500.00.
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The QA Technical Affairs/Document Control Associate is responsible for supporting the Technical Affairs/Document group in the creation, review, revision, oversight, and maintenance of all master and controlled cGMP documents generated at the site and maintaining both their physical and electronic records (e.g. in ETQ, Formulator, and SAP systems) as per company procedures and policies.
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Under general supervision, the Operator I performs a variety of processing duties according to packaging batch record and Standard Operating Procedures (SOP's) in the packaging department including, but not limited to set-up, filling, cleaning, case packing, and material handling.
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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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Educated and currently certified/licensed in the state of employment and according to state requirements as a Basic or Advanced Emergency Medical Technician (or equivalent) , Licensed Practical Nurse, Licensed Vocation Nurse, Paramedic or Registered Nurse.
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Follow feed mill Standard Operating Procedures. Learn and follow cGMP (Current Good Manufacturing Practices) in Feed Mixer's Guide. Kent Nutrition Group/Blue Seal, a member of theKENT®Corporation family of companies has a great opportunity to join their team as a Mixer in Waterloo, Iowa.
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Quality Assurance support areas include but are not limited to Batch Record Review, Product Release, Standard Operating Procedures, Investigations, CAPA, Change Control, Shop Floor Audits. The position is responsible for providing daily Quality Assurance support to the manufacturing site to ensure internal and regulatory cGMP and CFR requirements are met.
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Maintains thorough familiarity and ensures compliance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP.
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The Manufacturing Pharmacy Technician is responsible for compounding sterile preparations in an FDregulated 503b Outsourcing Facility, using aseptic technique and following Current Good Manufacturing Practices (cGMP.
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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.
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Responsibilities of the position include performing visual inspections on filled product off the filling line following Standard Operating Procedures (SOP) and current Good Manufacturing Processes (cGMP.
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High school diploma or equivalent AND minimum 3 years experience as a maintenance/mechanic or related specialty working in a cGMP regulated environment in a pharmaceutical or biotechnology facilities, consumer products, packaging and/or manufacturing department(s) REQUIRED.
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