Quality Systems Document Coordinator

1 month ago

Tipp City, Ohio, United States Abbott Laboratories Full time

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 Systems Document Coordinator

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 plan
  • 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 + 3 personal days + 10 paid holidays
  • Retiree Healthcare program
  • Robust 401(k) retirement savings with a generous company match
  • 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 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.

The Opportunity

This position works out of our Tipp City, OH location in the Abbott Nutrition division. 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.

Tipp City, Ohio, is one of Abbott's newest nutrition manufacturing facilities with technology that enhances production efficiency and product quality. Join us and you'll be part of a family that's dedicated to innovation and excellence and dedicated to nourishing millions of families around the world.

What You'll Work On

  • Implement and maintain the effectiveness of the quality system
  • Update, track, issue, and implement all Master Work Orders and all other quality-related documents (including QA controlled forms, Labeling Material changes, procedures, policies, Deviations, lab methods, acceptance programs, etc.) in accordance with the Quality Assurance Document Policy.
  • Assure Work Orders are issued with correct specifications, critical factors, formulation, and packaging materials
  • Print, verify, and distribute to the various manufacturing departments of batch specific plant production Work Orders
  • Ensure Work Orders and all other documentation are up to date and correct thus preventing the possibility of an FDA observation, Corporate Compliance Audit observation, product recall, or the possibility of serious errors that could adversely affect the nutritional efficacy, physical or microbiological stability of the manufactured product
  • May perform LIMS test mapping for Analytical testing
  • Writes, updates, revises, and prints merged Work Orders and/or procedures on the AS400 system
  • Update the valid combination files associated with the Master Work Order that includes inputting and formatting the correct data into the Batch Calculation program
  • Write, updates, routes, tracks, issues, and implements all Master Work Orders and Quality related documents in accordance with Division Quality Assurance Documents Policy
  • Coordinate changes in the labeling and packaging materials with the correct formulations as required by the Master Specifications Manual
  • Change control of Work Order and other QA documents - coordinate document changes with Plant and Division representatives
  • Arbitrate and resolve differences among various departments to assure that proposed changes follow the Plant, Division, and Corporate guidelines
  • Reviews process changes accurately before submitting to Sr. Documents Coordinator

You'll be accountable for meeting our compliance standards including FDA, OSHA and Abbott policies and procedures.

Required Qualifications

  • High School Diploma/GED or equivalent experience
  • Knowledge of applicable regulatory standards and requirements for infant formula and nutritional's
  • Technical knowledge of manufacturing processes associated with making a batch
  • Proficient skills with computer and management information systems

Preferred Qualifications

  • Knowledge of the AS400 word processing system is desired
  • QA related experience (ex. Lab Analyst, Batch Log Auditor, or related position)

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. Pre-Employment Inquiries and Citizenship | U.S. Equal Employment Opportunity Commission )

Apply Now

Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

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 and Military/Veteran friendly Employer, committed to employee diversity.

Connect with us at , on Facebook at , and on Twitter @AbbottNews.

The base pay for this position is $18.25 – $36.45 per hour. In specific locations, the pay range may vary from the range posted.

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