Test Control Procedure (TCP) Specialist

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 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Test Control Procedure (TCP) Specialist Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. Youll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelors degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity At Molecular Diagnostics, we realize the potential of personalized care as the laboratorys most trusted and preferred source for molecular diagnostic solutions. We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics. Position: Test Control Procedure (TCP) Specialist Location: Molecular Diagnostics Business Unit, Des Plaines, Illinois The Test Control Procedure (TCP) Specialist is responsible for conducting quality-related activities to deliver consistent, high-quality documents, services, products, and processes. What Youll Work On Responsible for implementing and maintaining the effectiveness of the quality system. Create, analyze, and process electronic Quality testing documents in compliance with QSR, ISO13485, and other applicable standards. Initiate Document Change Requests and associated packages relating to electronic documents and verify for correctness of the submitted Change in alignment with testing site requirements. Participate in project teams to further develop efficient and effective electronic Quality testing and ancillary documents. Create, analyze, and process electronic Quality testing and ancillary documents for new product development and on-market updates. Assist in resolving complex issues, provide judgment and recommendations to the manager. Assist in defining and documenting departmental procedures and standards to meet Regulatory and Division requirements. Provide customers (internal) with technical assistance in the development and execution of the electronic Quality testing document. Build and maintain successful cross-functional relationships with internal departments such as R&D, Manufacturing, Quality Control, Regulatory Affairs, and Operations. Be able to work with a diverse and dynamic international team providing support for multiple sites. Perform and support data mining activities. Required Qualifications Bachelor's Degree or an equivalent combination of education and work experience. 2-5 years of related work experience with a good understanding of specified functional area. Working knowledge and application of business concepts, procedures and practices. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a general knowledge of technical alternatives and an understanding of their impact on the systems environment. Preferred Experience on LIMS system and capable for authoring test procedures in LIMS and understanding the process. Experience with IBM Cognos and/or Microsoft Power BI is a plus Knowledge of regulations and standards affecting IVDs and medical devices, e.g. ISO13485 Excellent written, verbal and interpersonal communication skills Works effectively with others while providing high level customer service Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews. The base pay for this position is $60,000.00 $120,000.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Quality Assurance DIVISION: AMD Molecular LOCATION: United States > Des Plaines : DP01 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Work in a clean room environment Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions across the spectrum of health, around the world, for all stages of life. Whether its next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of lifes greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter