TCP Quality Documentation Specialist

Abbott Laboratories • Lewes, DE

7d • $60,000 - $120,000

About The Position

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. TCP Quality Documentation Specialist Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll 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 high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries around the world 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 a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity Our location in Abbott Park (Lake Bluff), IL currently has an opportunity for Test Control Procedure (TCP) Specialist. This team member will conduct quality-related activities to deliver consistent; high quality documents; services; products and processes.

Requirements

• Bachelor's Degree plus 2-5 years of related work experience with a good understanding of specified functional area, or an equivalent combination of education and work experience.
• 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.

Nice To Haves

• 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.

Responsibilities

• 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, provides judgment and recommendations to manager.
• Assist in defining and documenting departmental procedures and standards to meet Regulatory and Division requirements.
• Provide customers (internal) with technical assistance in 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.

Benefits

• 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 high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees