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This includes TSCA, REACH, HALAL, KOSHER, cGMP, FDA/Food Grade/ITAR-EAR, etc., and includes both our produced substances as well as those in purchased raw materials. The Product Stewardship Lead is responsible for regulatory compliance through proactive management of both internal and external Regulatory aspects.
$78,000 - $125,000Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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The Quality Assurance Specialist works closely with all facility personnel to ensure excellent quality performance and full compliance with cGMP and Food Safety requirements. The Quality Assurance Specialist is responsible for the management of quality systems to ensure compliance with quality and regulatory requirements and corporate quality standards.
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This person must comply with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Laboratory Safety and any regulatory requirements. Lief also houses a state-of-the-art, full-service Current Good Manufacturing Practice (cGMP) manufacturing facility, which offers custom solutions for a multitude of supplement categories.
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Maintain compliance with SOP, current Good Manufacturing Procedures (cGMP) and regulatory guidelines. With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide.
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Prefer Operational Excellence experience in a regulated industry such as pharmaceutical, nutraceutical or food processing industries, with familiarity of cGMP and other regulatory requirements.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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There are so many ways Octapharma Plasma can enhance your life and your career. And if you know someone else who'd be a great fit at Octapharma Plasma, Inc., please forward this posting along! More About Octapharma Plasma Inc.
$17 an hourExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Must be knowledgeable of AABB, CAP FDA (cGMP) and NJDOH regulatory guidelines for the Transfusion Service and Blood Center. Knowledge of AABB, CAP and FDA regulatory guidelines for the Transfusion Service and Blood Center.
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Basic knowledge of regulatory compliance inclusive of cGMP, OSHA, EPA, FDA regulations. ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.
ExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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Knowledge of cGMP and other regulatory requirements related to manufacturing of biologics and monoclonal antibodies. Establish microbiological standards to enable best practices and ensure cGMP compliance across QC and Mass Bio Ops.
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Provide Quality Engineering oversight and direction for multiple concurrent product development programs to ensure product & process compliance to all applicable regulatory and cGMP requirements.
$110,000 - $125,000ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Strong familiarity with regulatory / compliance environment (cGMP, GLP) associated with parenteral drug manufacture. The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Quality Management System standards, compiles monthly Quality metrics for internal and corporate review, and analyzes trends to implement corrective and preventive actions to mitigate adverse trends.
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Support the ongoing update of the QMS in line with emerging issues or changes to regulatory expectations. In depth knowledge of cGMP, cGDP, relevant ISO standards and medical device requirements.
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We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.
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Collaborates with internal functions and aligns goals and objectives for pre-clinical to commercial phase programs and products, ensuring cGMP, GCP, GVP and GLP compliance and realization of other value-added guidelines and best practices.
$315,000 - $320,000 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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The Manufacturing Associate I perform and documents cGMP activities to support upstream or downstream production areas and operations. Possesses a basic knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management.
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