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. **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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program, and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 communication skills. + Must know correct English grammar and syntax. + Good people relations, able to work independently with good administrative and time management skills. PC and Microsoft Office experience. + Must be able to perform detailed, careful work, including proofreading of numerical values, equations, etc. + Ability to resolve differences among various departments to assure that proposed changes follow the Plant, Division, and Corporate guidelines. + Ability to complete tasks independently with limited supervision from Management. **Accountability:** + Accountable to Abbott Nutrition Global Documentation management to assure the appropriate control and maintenance of AN division level specifications. + Without division level documentation the plants could not manufacture product or implement and maintain the necessary Quality System elements. + Accountable for review and approval of division product documentation to meet product launch dates. + It is the responsibility of this position to resolve documentation issues preventing the issuance of product documentation in a timely manner so as not to halt or delay production. + Failure to produce accurate documents in a timely manner can result in manufacture of adulterated products and/or unfavorable regulatory action. + Accountable to proactively elevate issues and propose effective solutions. **Scope:** + This position is responsible for the final release of AN technical and quality documents and is the individual who assures the information is correct to the best of their ability, the proper approvals have been attained, all other document references are correct. + Undetected errors at this level have the potential to cause significant negative impact in the areas of compliance, regulatory and manufacturing. + This may require challenging individuals higher in the reporting structure as necessary. **MISC:** + This is an on-site role - not a remote role. + There is no relocation provided for this role. Apply Now (https://www.jobs.abbott/us/en) **Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives** **:** www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx) 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 and @AbbottGlobal. The base pay for this position is $66,700.00 – $133,300.00. In specific locations, the pay range may vary from the range posted. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com