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The Role:The Director of QA Operations is responsible for quality assurance oversight of the daily operational activities for the manufacturing and testing of the cell and gene therapy products at our BaseCamp facility in Waltham, MA. This role provides leadership to ensure that cGMPs are maintained and product is manufactured at the highest quality.
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Quality Operations and Batch Disposition:Provides GMP Quality Assurance oversight of AVEO products manufactured at Contract Development Manufacturing Organizations (CDMOs). The Director of Quality Assurance at AVEO Oncology reports to the Vice President Quality Assurance and is responsible for Quality Operations at AVEO including quality strategic leadership and compliance activities related to the cGMP manufacture and release of AVEO products.
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DPS Group is seeking a qualified Senior Quality Assurance Operations professional to perform batch disposition, batch record review, deviation, CAPA and change control support at the Boston, MA client site.
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Reporting to the COO, The Vice President, GxP Quality Assurance is responsible for establishing and leading Aveo’s Quality Management System (QMS) operations and ensuring compliance with Local, State, Federal, and International regulations and standards associated with GXPs and Quality Systems in a fast-paced, primarily virtual development environment.
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Position Overview: The Senior Director of GMP Quality Assurance will report to the VP of Quality. You will develop and implement a GMP quality assurance strategy that ensures compliance with regulatory requirements, applicable guidelines, and industry best practices.
$260,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Experience in Quality Assurance and Quality Control for onshore / offshore wind projects, preferably specific to Turbine supply and installation. Risk Management: Effectively manage project risks, specifically those intrinsic to the offshore wind industry, manufacturing, Quality Assurance/Quality Control, and supply chain challenges.
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Provides GMP Quality Assurance oversight of AVEO products manufactured at Contract Development Manufacturing Organizations (CDMOs). Provide strategic direction and oversight of Quality Assurance activities across all stages of product development and commercialization.
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Experience in Quality Assurance and Quality Control for onshore / offshore wind projects, preferably specific to Turbine supply and installation Bachelor's degree in Engineering, Quality Management, or a related field.
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The Senior Quality Assurance Engineer II will perform as a member of a dynamic software engineering team developing the infrastructure necessary to support energy storage systems. Experience in testing remote access VPN, site-to-site VPN, Cisco Routers, Cisco Firewalls, Cisco Switches, SD-WAN, Meraki.
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Minimum 10 years in quality assurance management and compliance, ideally with cell therapy/viral quality systems, or similar within the pharmaceutical, medical technologies, biologics, or similar industries.
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Executes quality assurance reviews of core audit activities i.e. audits, issues validation, audit plan documentation and coverage, and other special projects, using predefined attributes and challenge questions, relevant for the review type and in accordance with the QA strategy.
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Our New England Process Safety Engineering team is responsible for upholding and helping our organization implement the Process Safety Management System (PSMS), Risk Control Standards (RCSs) and a wide variety of risk assessment and assurance efforts within our Process Safety space for our Major Hazard Asset (MHA) businesses.
$33 an hourInternExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression. Proven track record in Active Pharmaceutical Ingredient process development, including scale-up and technology transfer, coupled with a deep understanding of synthetic organic chemistry.
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Must have strong knowledge of biologics and small molecules manufacturing, materials management, quality control, quality assurance and CMC regulatory requirements. The position is responsible for product development, technology transfer and overall management of CMC activities related to ensuring robust development and reliable GMP supply of oligonucleotide conjugates and intermediates.
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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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assurance job Company: Google in Medford, MA
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