Quality Documentation Specialist - Nutrition - Abbott Park, IL

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:

Quality Documentation Specialist

Working at Abbott

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives.

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. 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 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 bachelor’s 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

This position works out of our Abbott Park, IL location in the Nutrition Division.

Primary Function/ Primary Goals/ Objectives:

The primary function is to review and process change request packages to maintain necessary division level documentation consisting of policies, procedures, and/or product specifications.  Function in an advisory role regarding document management and change control practices.  This individual should be able to independently manage and serve as the primary editor for a defined category of documents.

What You’ll Work On

• Review change request packages and documentation for assigned document types.  This may include but is not limited to: product manufacturing, packaging and testing, and quality system documents.  The incumbent ensures that any changes made are documented, justified, and approved by the required functional areas according to established procedures.
• Interact with change request initiators and approvers to resolve discrepancies.  Utilize various software programs for document review, cross-referencing and distribution.  Support use of change control systems, including providing training, resolving questions and proposing changes/improvements. 
• Provide assistance on projects according to areas of expertise.  Complete special projects and routine work on schedule.
• Maintain documents and data according to standard operating procedures.
• Provide guidance to stakeholders in the understanding of the QSD structure or change control process.  Provide technical writing support to subject matter experts and change request initiators.
• Convey technical expertise via solid written and oral communication.
• Must be able to rearrange priorities on short notice to react to (internal) customer needs and / or provide audit support.

Required Qualifications

• Bachelor’s degree is required.  A major or minor in a scientific discipline is highly desirable.
• Minimum of 2 years of Nutrition, Device, Pharmaceutical or other health care/industry experience in related operations areas such as manufacturing, materials management, quality control, quality engineering, document control, compliance, auditing, engineering and/or regulatory.
• Knowledge of regulations and standards affecting documentation and system requirements.  Knowledge of cGMPs.
• Knowledge of policies and procedures impacting documentation and documentation practices.  Strong oral and written communica