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This incumbent serves as a key member of the site leadership team, and will interact routinely with Manufacturing Management, Operations, R&D, Sales and Marketing, as well as Corporate Quality and Regulatory Affairs.
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The QA Manager will support Civica's quality and regulatory technology implementation and ensure the software and applications comply and adhere to regulatory expectations, such as 21 CFR Part 11, data integrity, current Good Manufacturing Practice (cGMP) guidance documents, and GAMP5.
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The Validation Specialist, Quality Assurance, will provide QA oversight of commissioning, qualification and validation support to M-TC’s cGMP Cell Therapy Manufacturing facility as the products move through clinical trials and commercialization.
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The Quality Assurance (QA) Supervisor is responsible for maintaining Food Safety and Quality Assurance Management Systems to support manufacturing of wholesome and quality food.
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The Quality Manager supports the project team from preconstruction planning through project completion. Minimum of 5 years as a Quality Manager in Heavy Construction and Project environments.
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We are now looking for a Regulatory Data Office (RDO) Analytics and Reporting Senior Developer to join us in Global Regulatory Operations (GRO) within Regulatory Affairs. With a specific focus on regulatory compliance and data quality, data science and innovative development of systems and tools, the RDO Analytics and Reporting team is accountable for maximising the business value of our global Regulatory business data.
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Balance reporting requirements to multiple constituencies including; Centene Corporation regional vice president, state health plan president, chief operating officers and Corporate regulatory and government affairs staff.
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We seek outstanding candidates with teaching experience in the following: industry experience in entrepreneurship, drug/ medical device development, data science, regulatory affairs, clinical and medical affairs, quality management, project management, finance, business operations, research and development, biometrics, health economics and outcomes research or manufacturing.
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The Quality Assurance (“QA”) Manager will have primary accountability for developing and managing the plant QC environment for the production of bottled water. QA Manager will lead the plant in the implementation of the BlueTriton Quality System and will develop and continuously improve plant procedures for monitoring and ensuring conformance to specifications for incoming raw materials as well as for finished product.
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Develop, lead, direct, update, reassessment, verification and periodic validation of FSQA programs including HACCP Program, Sanitation Standard Operating Procedures, Pest Control, Good Manufacturing Practices, Approved Supplier Program, Foreign Material Control, Plant Sanitation, Chemical Control, Product Quality Assurance, FSQA Customer Complaints, Food Defense and Security.
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Job Summary: Manage the Quality Control and Assurance program for Project reporting administratively to Project Manager and functionally to Quality Director. Prepare weekly and monthly reports to Project Manager / Client / Quality Director.
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Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA to establish global submission activities and timelines in partnership with global and cross-functional stakeholders in Pharmaceutical Science, GMS, Biologics and Small Molecule operating units, Regulatory Affairs, and QA. Up to 20% domestic travel required.
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Communicate regularly and effectively in a cross-functional matrix with development, origination, fundamentals, finance, and political & regulatory affairs staff to translate regulatory and market issues into business impacts and opportunities to benefit the position of Pattern's new and core business interests in MISO and other priority markets.
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Monitoring of FSQA programs including HACCP Program, sanitation standard operating procedures, pest control, good manufacturing practices, approved supplier program, foreign material control, plant sanitation, chemical control, product quality assurance, FSQA Customer complaints, food defense and security.
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Provide consulting services to support the Veterans Affairs North Texas Health Care System Radiation Safety Office, including attending committee meetings and reviewing the overall technical quality assurance program.
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quality assurance manager manufacturing regulatory affairs jobs Title: sr manager
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