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Work closely with CMC team and key personnel including Quality Assurance, Regulatory, and Project Management, and with external CDMO and Contract Testing Laboratories to execute QC activities according to program needs and participate in external lab due diligence visits and audits as needed.
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Cisco Certified Network Associate (CCNA) Security - Cisco, GIAC Security Leadership Certification - Global Information Assurance Certification - GIAC, GSEC: GIAC Security Essentials Certification - Global Information Assurance Certification (GIAC.
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The Director of Pharmacovigilance Quality and Alliance Management will be a pivotal member of the Pharmacovigilance (PV) team, responsible for ensuring the highest standards of drug safety and compliance within Aveo Oncology.
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In-depth knowledge of Quality Risk Management (QRM) principles and applications. Led the Quality Operations group primarily responsible for providing quality oversight and support to the Vertex Manufacturing Center (VMC) Facility operation in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of analytical laboratory operations, and material management including engineering, validation/qualification, and facilities/utilities.
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What you’ll do Lead the QA program responsible for ensuring compliance of the company’s SaMD and other medical devices Lead the QA team in conducting supplier management, risk assessments, audits, inspections, Complaints, CAPAs, and NCs, and other quality control activities for SaMD and other medical devices, including both hardware and software components.
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Implement best practices in data management, ETL processes, and data quality assurance to maintain high standards of data integrity and reliability in Takeda Research. You will also work with scientists and with experts in data management, lab automation, molecular design, and machine learning in the Global Biologics organization to build and continuously improve data infrastructure.
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Oversee the development of study-specific CDM documentation such as eCRF specifications, eCRF completion guidelines, edit check specifications, and data management plans identifying and mitigating risks to data quality and proper inclusion into the Trial Master File (eTMF.
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Is knowledgeable regarding requirements for documentation, data submission, quality assurance and other reporting of UNOS, NEOB, CMS and other regulatory bodies and ensures compliance with Policy and Procedure for Data Submission to the OPTN. - Participate on committees and task forces that relate to organ transplantation.
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The Director, R&D Quality, GCP consults as necessary with quality and study teams on advanced GCP quality assurance oversight and management activities to ensure compliance with Good Clinical Practice (GCP) guidelines, applicable regulations, clinical protocols, and Vertex policies.
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Primary duties of the Trash Collector include: - Operating garbage trucks - Collecting and dumping trash receptacles - Following route assignments as directed Waste Management offers an excellent benefits package that includes medical, dental, vision, life, 401(k) savings and more.
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Experience with ESG/EHG sustainability software and analytics tools, data management, processes and controls mapping. Experience managing Scope 1, 2 and 3 corporate Greenhouse Gas (GHG) inventory data, sustainability KPI measurement, reporting and assurance.
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Extensive experience in pharmaceutical product development and quality assurance, with a focus on the veterinary sector. Develop and implement quality management systems that ensure compliance with cGMP requirements, tailored to each phase of the product development lifecycle.
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8+ years of audit (internal and/or external), quality assurance/review, internal controls and assurance, risk management, corporate governance, compliance and/or related experience required, with heavy preference for highly substantive audit, assurance, and internal controls experience.
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Contact: John@SourceRecruitmentSolutions.com Our client, a premier Food Manufacturing Company with products sold nation wide is seeking an experienced Quality Assurance Manager. 5+ Years Quality Assurance experience in a Food Production Manufacturing plant.
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Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression. By optimizing manufacturing strategies and fostering collaboration with cross-functional teams, the Director plays an instrumental role in enhancing efficiency, quality, and safety, driving innovation, and ensuring that manufacturing practices are in sync with QurAlis' core values.
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quality assurance supplier management jobs Title: director in Waltham, MA
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