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Abbott QC Manager in Des Plaines, Illinois

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.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and 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.

  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

  • An excellent retirement savings plan with high employer contribution

  • 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 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.

At Abbott Molecular, we realize the potential of personalized care as the laboratory’s most trusted and preferred source for molecular diagnostic solutions.

Our Des Plaines, IL site has an opportunity for a QC Manager.

The QC Manager is responsible for managing and improve the ongoing batch log auditing and product release system. Manage and improve plant quality control systems including document change control. Address nonconforming materials and other quality issues with Design Assurance, Process Authority, Medical, R&D and other appropriate groups outside the plant environment. Assist with managing the CAPA systems for the plant.

What You'll Do :

  • Documentation and Work Orders: Manage the site Documentation System and the QA Work Order systems.

  • Assure that 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 the 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 the Infant Formula Regulations, 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 nonconformance's.

  • 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). QUALIFICATION.

EDUCATION AND EXPERIENCE, YOU’LL BRING :

Required :

  • Bachelor's Degree

  • Minimum 1 year experience with regulatory standards and requirements for a food manufacturing environment is required.

  • Minimum 5 years Supervisory/Leadership experience

PREFERRED:

  • Preventive Controls Qualified Individual (PCQI)

WHAT WE OFFER

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

  • 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

  • Paid time off

  • 401(k) retirement savings with a generous company match

  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities

*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 Employer, committed to employee diversity.

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

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.

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 corpjat@abbott.com

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