Quality Systems Manager - Tipp City, Oh

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.

Nourish the world and your career as part of the Nutrition team 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®, Glucerna® and ZonePerfect® – to help get the nutrients they need to live their healthiest life.

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 WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• 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
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• Vacation – 3 weeks of accrued vacation (1st yr is prorated) + vacation buy program + 3 personal days + 10 paid holidays
• Company Paid Pension Plan
• 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 company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
• A stable company with a record of strong financial performance and history of being actively involved in local communities
• Annual merit increase, based on performance and Bonus targeted at 7%
• Secured parking, workout facility, uniforms provided, employee perks
• Clara Abbott Foundation
• Discounted products for family members

WHAT YOU’LL DO

As the Quality Systems Manager, you'll have the opportunity to lead a team while overseeing and improving the ongoing batch log auditing process, product release system, and quality control systems including document change control. You will also address nonconforming materials and other quality issues with Design Assurance, Process Authority, Medical, R&D and other appropriate groups outside the plant environment. This role is also responsible for the CAPA systems for the plant.

Additional responsibilities include:

• Documentation and Work Orders: Manage site Documentation System and QA Work Order systems. Assure all QA documents meet established divisional, corporate and regulatory standards and that these documents are an efficient, effective system for both their use and Quality Assurance. Identify gaps in Plant Documentation and Systems and take necessary actions to correct.
• Manage Change Control: Ensure change requests identify all documents affected and all appropriate parties are reviewing document prior to implementation to assure change control is achieved. Control product formulation changes and issuance to correspond with labeling materials. Assure that Technical Training is notified of changes so appropriate employee training is coordinated with departments affected and assure timely implementation of requested change.
• Oversee New Product Introduction: Assist with the coordination of plant activities for new product introductions and roll out.
• Manage Auditing and Batch Release: Assure that all QA documents are current with manufacturing systems and practices through annual audits. Manage the Batch Log System. Manage auditing of all batch records to assure that the batch files comply with all policies, procedures and regulations affecting the product. This includes Food cGMP’s, Kosher Laws and Low Acid Food Regulations. Provide batch release, discrepancy, non-conformity metrics to the plant and Division. Store and maintain all batch files to comply with Corporate and Division policies in a state of audit readiness. Issue Finished Product Shipping Releases in a timely manner for all conforming material goods. Coordinate priority finished product releases with Manufacturing and Logistics.
• Manage Non-conformance: Identify all batch non-conformance and initiate appropriate actions for those non-conformances. Control release of product to market and Quality Hold Program. Coordinate the quarantine of nonconforming finished product. Report status of materials not meeting normal release times (Hold List or Delayed Release List).

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• Bachelor's degree in related field
• Minimum of 1 year experience with the regulatory standards and requirements for a food manufacturing environment
• Minimum of 5 years of Supervisory/Leadership experience

Preferred

• Preventive Controls Qualified Individual (PCQI)

Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity and 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 $95,000.00 – $190,000.00. In specific locations, the pay range may vary from the range posted.