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Quality Assurance Specialist I

Company: Abbott
Location: Portsmouth
Posted on: September 3, 2019

Job Description:

Quality Assurance Specialist I REQ******** NA-USA-Virginia-Portsmouth DO WORK THAT MATTERS At Abbott, diverse ideas, perspectives, and expertise allow us to create life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals. We have an exciting opportunity for a Quality Assurance Specialist II within our Abbott Rapid Diagnostics business located at Portsmouth, VA. In this role, you will be a part of the ARDx Toxicology Distribution Quality Team, that provides support and direction to site and commercial leadership regarding quality and compliance issues. It is responsible for maintaining an effective and compliant Quality Management System (QMS) and processes that deliver product conformance and customer satisfaction, and are suitable for the activities performed by the site. Abbott Rapid Diagnostics (formerly Alere) is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides essential information for treatment and management of diseases and other conditions. RESPONSIBILITIES Supports development, implementation, maintenance and improvement of a QMS appropriate for the functions performed by the site. Communicates the importance of an effective and compliant Quality System to all employees, and supports the collection of quality metrics that allow assessment of QMS effectiveness. Supports complaint intake process in an accurate, professional and timely manner, including review of intake records for accuracy/completeness, escalation to manufacturing partners, and update to complaint files and customers as necessary, based on information provided by manufacturing partners. Prepares ad-hoc assigned quality metrics for site management and manufacturing partners. Supports critical quality processes, including CAPA, supplier management, quality training, document control, and others as assigned. May initiates and process Change Orders and support document and quality e-systems. Supports internal, external, and third-party audits. Assumes and performs other duties as assigned. Able to work flexible hours Overtime may be required. BASIC QUALIFICATIONS High School Diploma 2-3 yrs of experience working in a Quality Assurance or Quality Control role Work experience in an FDA or other regulated industry (Medical Device, Pharma, Food) Project Management or Delivery experience PREFERRED QUALIFICATIONS Bachelor's Degree in a Scientific or Biology or Biotechnology major Experience in preparing and performing training for staff. Analytical skills to assess regulations and operationalize improved workflows. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals Experience with Commercial Quality Experience with Commercial Excellence About Abbott Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries. Connect with us at ************** , on LinkedIn at ********************************* , on Facebook at *********************** and on Twitter @AbbottNews and @AbbottGlobal. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please send an email to *********************. #LI-KE1 Quality Operations/COS Full-time

Keywords: Abbott, Portsmouth , Quality Assurance Specialist I, Other , Portsmouth, Virginia

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