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Work with the department Associate Team Leaders and Team Leaders to ensure compliance with all cGMP, ISO and FDA guidelines for warehouse activities. Experience with the safe and efficient use material handling equipment such as a floor jack, hand truck, order picker, and forklift is preferred.
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Knowledge of FDA regulations, drug development and PM processes. Independently manages Biometrics project teams from study start-up through study closeout; departments include but not limited to, Data Management, Biostatistics, Statistical Programming, and Medical Writing.
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Preferred:Manufacturing site experience in manufacturing, business excellence or quality Experience in the Medical Device industry or medical field Knowledge of ISO13485 and QSR/EU MDD-MDR regulations Key front-room role experience with FDA (or similar) inspection and Notified Body inspectionsOther:Project management and Lean Six Sigma Black Belt certifications are preferred.
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Interact routinely and will develop a strong team environment with colleagues throughout GRSRequirements:Ph. D., M.D., PharmD. , MS or commensurate experienceSignificant experience in regulatory affairs (e.g. 3-5 years)Expert understanding of policy, laws, regulations and guidelines as they apply to U.S. FDA for drug development and approval.
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Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
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Familiarity of regulatory bodies such as Food and Drug Administration (FDA), European Medicines Agency (EMA), Japanese Pharmacopia (JP), etc. Familiarization with Annex 1, FDA Guidance for Industry, and other drug product regulatory guidance.
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Would you like to be a part developing & implementing quality procedures, managing quality systems, and ensuring the release of finished product meets FDA regulations? Responsible for internal and external audit programs including cleaning validations, coordination of pest control and outside water testing.
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Act as a back-up for Food Safety & Quality Assurance management staff members as assigned by Director of FSQA.Ensure facilities comply with FDA regulatory requirements related to product safety.
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One to 3 years of meat and/or seafood industry (as appropriate) experience at a federal CFIA/FDA meat and/or seafood processing plant (as appropriate). Formal job training in TQM principles, SPC, HACCP concepts, CFIA/FDA regulations would be beneficial.
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Work with junior CTM for oversight of Trial Master Files (TMF) oversight plan and liases with CRO for annual quality check; ensuring tracking of ICH-GCP and/or FDA CRF21 essential study documents.
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Mandatory Requirements to Succeed in Role· BS in Engineering· Medical device regulation/guidance (FDA, ISO)· Experience with the following:o Risk managemento Test method validationo Design Verification (Filing and Aging studies)o Process validationo Data analysis (JMP)o Statistical equivalence studies.
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Excellent understanding of the clinical research process, including US FDA, EU, and GCP regulations, and the function of quality control in clinical trial conduct. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
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Process Validation & Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and other regulatory requirements. Process Validation & Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and other regulatory requirements.
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Correctly date-marks food items, monitors for temperature control, and monitors “use by” dates, ensuring food items are stored so foods with earliest “use by” dates are used first (effectively uses ice wands or other mechanisms to safely cool food, defrosts food properly, used FDA guidelines for dating, minimizes time TTC foods are out of refrigeration, stores food in proper order in walk-ins, etc.
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While prior knowledge is always a plus, we are happy to provide thorough training on OSHA (Occupational Safety and Health Administration), FDA (Food and Drug Administration), and FSMA (Food Safety Modernization Act) regulations.
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