QC Manager

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:

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 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.

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.

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