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The role will report directly to the Senior Director Quality in a rapidly growing organization providing Medical Device and Combination Product development Services to an industry leading Client base.
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The Quality Assurance Specialist is responsible for supporting the Quality Management System throughout the organization in support of product maintenance, development, and growth.
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The QA Specialist will perform activities in support of disposition of product while ensuring compliance with Thermo Fisher directives and procedures, customer requirements, and regulatory standards.
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The QA Specialist will support plants in quality and food safety investigations, policy development and implementation of corporate policies/programs. Lead Quality Assurance systems in order to satisfy internal and customer requirements to include process evaluation and product protection programs; process specifications and standards; sanitation programs, HACCP and GMP programs; production labeling; and product storage and distribution.
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The Senior Quality Assurance Specialist provides Quality support for Petaluma site and ensures adherence to cGMP compliance in a regulated environment. Support new product development and CMO activities for pharmaceutical products.
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Communicate effectively with R&D, production, maintenance, warehouse, and other functions to enable process and/or product optimization, problem prevention, ensure Quality systems are performing optimally, and identify and apply best practices across multiple sites.
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Qualifications Bachelor’s degree in Life Sciences, Engineering, or a relevant field of study from an accredited university required Minimum of ten (10) years of QA and/or related quality experience in manufacturing, utility and/or packaging systems required, preferably in the pharmaceutical or medical device field Demonstrated expertise in Regulations & quality systems (e.g., product disposition, Deviations/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, etc.
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The Quality Assurance Specialist identifies all batch nonconformances for final audit/review and initiates appropriate actions for those non-conformances when needed, and issues Finished Product shipping releases in a timely manner for all conforming material goods.
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The Quality Assurance Specialist will, with direction, be responsible for document management, QMS training, complaint and CAPA management. When you join RadNet as a Quality Assurance Specialist , you will be joining a dedicated team of professionals who deliver quality, value, and access in the 21 st century and align all stakeholders- patients, providers, payors, and regulators achieve the best clinical outcomes.
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What You’ll Work OnThe Quality Assurance Specialist identifies all batch nonconformancesfor final audit/review and initiates appropriate actions for those non-conformances when needed, and issues Finished Product shipping releases in a timely manner for all conforming material goods.
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SFI is currently looking for a Software Quality Assurance Specialist that will be responsible for ensuring the quality of the software product by developing and executing test plans, identifying and reporting defects, while working with development teams to ensure defects are addressed.
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Element has an exciting opportunity for a Quality Assurance (QA) Specialist to join our team, located in Santa Rosa, California. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.
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As a Senior Quality Assurance Specialist , you will be responsible for maximizing crew quality performance within the Spartanburg Site. In this role, you will be expected to have an in depth understanding of the input variables and measurement systems in our production equipment, and their impact on final product quality.
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Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
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As a quality assurance specialist , you will. Work with manufacturing quality assurance team to develop, implement and manage programs related to product and process quality, food safety, and regulatory compliance.
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product specialist development jobs Title: specialist quality assurance
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