Documents Coordinator

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 115,000 colleagues serve people in more than 160 countries. ## **JOB DESCRIPTION:** **ABOUT ABBOTT** Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. **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. You’ll also have access to: - Production areas that are **clean, well-lit and temperature-controlled** - **Training and career development**, with onboarding programs for new employees and tuition assistance - **Financial security** through competitive compensation, incentives and retirement plans - **Health care and well-being programs** including medical, dental, vision, wellness and occupational health programs, **Medical Benefits start day 1** - **Vacation – 120 hours of accrued vacation (1st yr is prorated) + vacation buy program + 5 personal days + 10 paid holidays** - Retiree Healthcare program - **Robust 401(k)** retirement savings with a generous company match - 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 around the world and named one of the most admired companies in the world by Fortune. - **A stable company** with a record of strong financial performance and history of being actively involved in local communities - 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. **OVERVIEW** Audit and assure accuracy of batch records to be compliant with policies, procedures and regulatory requirements. Assure compliance to Federal Regulations pertaining to Low Acid Canned Foods, Infant Formula Act, Acidified Foods, Nutritional Labeling Laws, and Good Manufacturing Practices. **WHAT YOU’LL DO** - Responsible for implementing and maintaining the effectiveness of the quality system. - Determine appropriate release criteria and communicate with DQA, PR&D, and 3rd Party Manufacturers on document requirements, documentation guidelines and audit discrepancies. - Initiate Exception Reports (ERs) and Plant Information Reports (PIRs) and route for disposition. - Enter and maintain work orders, ERs and Standard Quality Evaluations (SQEs) into the Release Batch Activity (RBA) system. - Use of CAMBAR and AMAPS to adjust or obtain release status for specific batches. - Audit and maintain records on non-batch related items (i.e.: Storage Temperature Logs). - Coordinate isolations, holds, and reworks. Resolve discrepancies and deviations prior to final review. - Reconcile product inventories with the amount of product that was manufactured. Track and report quality statistics. - Assist and backup coordinators and auditors when needed. Train and provide work for contract workers. Responsible to train new employees where needed. - Assist Supervisor as business needs dictate. Ensure holds and isolations have been initiated and address as required and verify all sort/destruct issues are completed and documented in work order. Complete final batch review of work orders ensuring all critical items are in compliance with regulations before submission to Supervisor when needed. - Enter corrections and cor…