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Expert level knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to biologics / cell therapy manufacturing.
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Complies with health and safety requirements and with regulatory agencies such as DPH, etc. Opportunities with Reliant Medical Group, part of the Optum family of businesses. Join a team at the forefront of value-based care and discover the meaning behind Caring.
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Requirements: Master's degree in higher education/student affairs; diversity, equity and inclusion; or related field is required; Doctorate preferred. Serve on committees and working groups focused on diversity, equity and inclusion as requested, such as but not limited to the Committee for Diversity, Equity, Inclusion and Belonging and/or the Student Affairs Diversity, Equity, and Belonging Committee.
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Knowledge and experience with regulatory agency requirements such as NFPA, ASME [U] and [R] codes Organizing and planning work schedules Work order analysis & blueprint analysis to determine need for supplies and sequence of operations required Blue Print Reading& understanding assembly of sub components & building fixtures PREFERRED SKILLS: Two year degree, apprentice or secondary training in Weld Technology/Inspection Technology.
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Adhere to all state and federal regulations, if applicable, as set forth by the US Department of Transportation (DOT), Occupational Safety and Health Administration (OSHA), Mine Safety and Health Administration (MSHA), or any other regulatory agency.
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10+ years of relevant experience in the pharmaceutical, biopharmaceutical or related industry Certification in lean manufacturing principles and Six Sigma toolsOperations experience in pharmaceutical manufacturing to cGMP standards including extensive knowledge of regulatory guidelines and validation practicesWorking knowledge of pharmaceutical development and commercialization processes.
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Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations- Reviews and approves Quality, Quality Control, Validation and Automation related documents- Review and approves Standard Operating Procedures (SOPs.
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Organizational Skills - creative thinking, analyzing issues, decision making, collaboration Fluency with Microsoft Office and Excel with excellent writing skills Excellent communication skills, both written and verbal are required Ability to work independently and effectively collaborate with teams Hands-on experience in a laboratory setting and basic knowledge of chemistry is a benefit Familiarity with relevant quality, regulatory and ICH guidelines highly desirable.
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Provides Records Management support during regulatory agency inspections and corporate audits. Manages and executes the initiation, processing, routing, distribution and archiving of cGMP documentation.
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All positions must strive to support WFM core values and goals, promote national, regional, and store programs and initiatives, and ensure adherence to all applicable health and safety regulations including Food Safety and regulatory duties required in the department.
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We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Voluntary Benefits (pet insurance, legal insurance, LTC Insurance, etc.
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Ensure compliance with Executive Office of Elder Affairs (EOEA) Regulations and ASNCM policies. Passion for working with the elderly community and an interest in human services and non-profit organizations.
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Ensures that vehicle manifests, labeling and load are in compliance with regulatory guidelines such as those pertaining to the Department of Transportation (DOT), Environmental Protection Agency (EPA), Federal Motor Carrier Safety Administration (FMCSA), Food & Drug Administration (FDA), Occupational Safety and Health Administration (OSHA), and Airgas safety standards (SAFECOR.
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A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.
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The Internal Audit department reviews the enterprise risk management evaluation of Credit risk, Financial Reporting risk, Legal risk, Liquidity risk, Market risk, Operational risk, Regulatory risk and risk to the Bank's reputation.
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regulatory affairs jobs in Fitchburg, MA
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