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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.

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.

**This position works out of our Columbus, Ohio plant 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.

The Columbus Plant is Abbott’s first manufacturing facility in the world, making us a leader in science-backed nutrition products. Working here, you’ll be part of a family that works together to produce quality products that make a difference and help keep consumers nourished at every stage of their lives.

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 + 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 (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.

WHAT YOU’LL DO

+ Responsible for implementing and maintaining the effectiveness of the quality system.

+ Audit all batch records to assure that the batch files comply with all policies, procedures and regulations effecting the product.

+ This includes the Infant Formula Regulations, Food GMP’s, Kosher Law and Low Acid Food Regulations.

+ Provide Batch Log trend information to the plant and Division.

+ Develop systems to track, trend, report and reduce Nonconformance issues.

+ Store and maintain all batch files to comply with Corporate and Division policies in a State of audit readiness.

+ Identify all batch non-conformances and initiate appropriate actions for those non-conformances.

+ Assure that continuing non-conformances have follow-up action plans to correct the problem.

+ Manage corrective action plans with supervisors and managers for discrepancies of problem areas.

+ Manage corrective action plans with supervisors.

+ Assure validation requirements are fulfilled on plant wide changes prior to product release.

+ Manage the Material Review Board.

+ Follow up on all activities assigned during MRB meetings.

+ Issue Finished Product shipping releases in a timely manner for all conforming material goods.

+ Report status of materials not meeting normal release times (Hold List).

+ Coordinate priority finished product releases with Manufacturing and Logistics.

+ Coordinate requests for rework and destruction of materials.

+ Provide follow-up to batch investigations concerning customer complaints in the RPIC system.

+ Coordinate surveillance batch execution for Division.

+ Develop and issue quality reports related to problems, routine QA data, and those systems under QS responsibility. 17.

+ Conduct annual performance reviews with all direct reports.

+ Manage performance development plans for all employees in QS.

+ Assure all required training is provided and completed by all dept. employees.

+ Promote and support team development activities.

ACCOUNTABILITY/SCOPE:

+ The Batch Records Supervisor assures that all batch work orders are in compliance with the standards established by Abbott Nutrition and other regulatory agencies before product is released to market.

+ Failure to up hold these standards could result in product recall, loss of market share and/or consumer endangerment.

+ The Batch Records Supervisor is also responsible for managing the plant and Division performance goals, Quality Hold Program, development of nonexempt personnel and maintains activities of the Material Review Board.

+ Maintaining and improving the ongoing batch log auditing and batch release system.

+ Address Nonconformance issues with Plant management, Division and other appropriate groups.

+ Maintain activities of the Material Review Board.

+ Auditing all product related information and systems for compliance to Federal regulations, Abbott Corporate and Ross Divisional Policies and procedures.

+ Managing the corrective and preventive action systems to assure identification and reduction of recurring quality issues regarding batch nonconformances.

+ Maintaining and guiding the activities of the Material Review Board.

+ Tracking and maintaining all Plant and Division Quality goals.

+ Supporting the FDA, Corporate Compliance and Plant Sanitation and Housekeeping audits.

+ Maintaining and updating budgetary plans.

REQUIRED QUALIFICATIONS

+ Bachelors Degree (Technical Area Preferred) or equivalent experience

+ Low Acid Food School

+ Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals.

+ Relevant experience in Quality Assurance and /or Manufacturing required.

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 (eeoc.gov) (https://www.eeoc.gov/pre-employment-inquiries-and-citizenship)

**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)

*Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

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

Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott , and on Twitter @AbbottNews.

The base pay for this position is $60,000.00 – $120,000.00. 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 [email protected]