QA Operations Manager - Sturgis, MI Plant

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.

     

JOB DESCRIPTION:

Job Title: QA Operations Manager

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: 

• 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 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 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 Sturgis, MI 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. 

For over 70 years, Abbott’s Sturgis, Mich., has been impacting its community while producing products that provide essential nutrition to millions of families around the world. Working here, you’ll feel part of a family that is dedicated to making a difference and helping others. 

What You'll Work On

The Quality Assurance Operations Manager manages subordinate QA groups within a manufacturing plant with the focus of ensuring the accuracy of quality documentation. Primary responsibilities would include, but not be limited to, new product registrations, change management of existing documentation, batch record review, and product release. The position would also set the strategy for their areas of responsibility to ensure the site maintains best practices for quality document control.

• Responsible for the detailed end-to-end review of all batch documentation to ensure compliance with all policies, procedures, and regulations related to the product up to and including CAPA, interventions, and environmental monitoring data prior to batch release for commercial distribution.

• Accountable for Batch Release Process Management, which would include identifying all batch non-conformances and initiating appropriate actions for those non-conformances.

• Control the release of product to market and coordinate the quarantine of nonconforming finished products.

• Maintenance of batch release, discrepancy, and non-conformity metrics and tracking MSP performance with other site departments.

• Review and approval of all change requests to site-related documentation and assessment of all Corporate and Divisional policy updates.  

• Partner with affected groups to ensure change control is maintained and site training is updated to reflect changes.  This would include new product introductions, label copy adherence, and product certification.

• Accountable for maintaining the site Documentation system and QA Work Order systems.  

• Ensure that all QA documents meet established Abbott and regulatory standards and that these documents are stored in an effective system.

• Identify gaps in Plant Documentation and systems and take necessary actions to correct.

• Responsible for Executive Leadership activities – setting strategy for teams, employee development, and effective change management in relation to quality documentation.

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

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