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Ensure compliance with customer specifications and quality standards (e.g. Food and Drug Administration (FDA), United States Department of Agriculture (USDA), HACCP etc.) Proven understanding of Good Manufacturing Practice (GMP), FDA, USDA, and HACCP regulations.
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Complies with policies, procedures, and initiatives of laboratory services, the hospital, and system; understands, communicates and complies with standards and conditions set forth by various governmental and accrediting agencies including TJC, FDA, CAP, AABB, CMS, HCFA and CLIA.
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DUTIES & RESPONSIBILITIES Ensure facilities, security, and accountability according to DMCR, FDA, GCP guidelines, and other regulatory requirements. Pharmacy Director (Remote position) The Pharmacy Director in the area of Investigational Drugs will oversee clinical, operational, financial, regulatory and human resources management of all research and investigational drug services.
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Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval.
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Fellows will be supported by a bio-statistician from the Center for Outcomes Research (COR) at Houston Methodist Hospital. There is ample opportunity for collaborative, multi-disciplinary projects though the Houston Methodist Hospital and Texas Medical Center.
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Assist with food safety and quality audits conducted by regulatory agencies (USDA, FDA, Health Department, Military Veterinary Command), third-party certifying auditing companies, and customer audits.
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Ensures compliance with facility SOP’s, State and Federal (FDA) Rules and Regulations, OSHA requirements and CLIA requirements. Certification as a Sr. Medical Screener, Phlebotomist and St. Processing Technician required or ability to obtain certification within six months of acquiring position.
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Prevents and helps with researching information for management to respond (corrective action / preventive action) and follow up to Government (Federal - USDA / FDA / etc., State, County and City) inquiries.
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Support engagements with regulatory authorities (e.g., FDA, EMA) on behalf of customers, across the lifecycle of drug development from pre-clinical to licensing, including contribution to briefing documents and other meeting materials, and attendance and contribution to meetings and other interactions.
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Ensure adherence to all relevant regulatory requirements, including FDA guidelines, IRB approvals, and Good Clinical Practice (GCP) standards. Ensure adherence to all relevant regulatory requirements, including FDA guidelines, IRB approvals, and Good Clinical Practice (GCP) standards.
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Working with the world-class Principal Investigator, the Director will coordinate the Research & Development activities for novel medical chemistry compounds and drive them towards the FDA IND. The Director will be responsible for project budgets, timelines, milestones and coordination activities.
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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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O Ensure all CQV activities are in compliance with relevant standards and regulations (e.g., FDA, GMP, GAMP). PharmEng is looking for a detail-oriented and results-driven CQV Engineer to play a key role in ensuring the successful commissioning, qualification, and validation of Manufacturing equipment and building expansion including WIP skids, AHUs and dust collectors and other miscellaneous equipment.
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1-year minimum experience in a fast-paced manufacturing environment; preferably in cosmetics process manufacturing or an FDA regulated industry is preferred. All work must be carefully and accurately performed and documented to meet requirements set by our customers and by the FDA. Anything less than the complete compliance in these areas may result in significant liability to the company and the company's reputation.
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Ensure compliance with local, state, and federal regulatory agencies, such as OSHA, AIB, FDA, and USDA. Ensure compliance with local, state, and federal regulatory agencies, such as OSHA, AIB, FDA, and USDA.
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fda job in Houston, TX
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