Nonconformance CAPA Investigator

Abbott Nutrition

Abbott Park, IL


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.

The Opportunity

This position works out of our Lake Bluff, IL location in the Transfusion Medicine Division. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

As the Nonconformance CAPA Investigator, you’ll author nonconformances (NCRs), investigate quality issues to root cause, develop/implement appropriate CAPA, and monitor CAPA to ensure effectiveness to support Manufacturing, Supplier Development, New Product Development, and Quality Systems and support projects to ensure the manufacture of high-quality product and to facilitate compliance with regulatory requirements.

What You’ll Work On

  • Support the development, implementation, and continuous improvement of Quality System Nonconformance/CAPA procedures, software, and training.

  • Is a subject matter expert on nonconformances, investigation, and root cause analysis techniques to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance.

  • Ensures all documentation is managed in a complete, clear, concise, and controlled manner.

  • Investigates issues with little management oversight. Provides solutions to a wide range of problems. Solutions are compliant, innovative, thorough, practical, and consistent with organizational objectives. Ensures compliant documentation in area of responsibility.

  • Demonstrates good, general understanding of the standards and regulatory bodies that regulate our industry. Ensures compliance to site level policies and procedures and demonstrates a solid understanding of Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate. Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues.

  • Provides solutions to a wide range of difficult problems. Ensures that solutions are compliant, innovative, thorough, practical, and consistent with organizational objectives. May lead projects with cross-functional or broader scope.

  • Interacts effectively with employees, managers, and cross-functional peers. May represent own team while on cross-functional project teams with other functional leaders. Communicates confidently and effectively with management, peers, and key stakeholders.

  • Produces trending metrics and reports to identify, prioritize, and manage further actions, as may be required.

  • Position involves interactions across multiple functional areas including operations, R&D, Marketing, Supply Chain, Quality and Regulatory.

  • Ensure that records are complete, and they contain accurate links and references to other Quality processes such as Change Management, Non-Conformance, and Complaint Handling.

  • Critical Review of documents. Experience in assessing the weight of evidence associated with a claim/hypothesis/assertion.

  • Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.

  • Provide ongoing support to Quality management during external audits.

  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing, and testing activities.

  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships.

  • Carries out duties in compliance with established business policies.

  • Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.

  • Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.

  • Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit.

  • Monitors compliance with company policies and procedures (e.g., compliance with FDA, BSI, EEO regulations etc.).

  • Identifies, develops, and implements processes to improve department performance.

  • Monitors departmental activities and records to ensure compliance independent action through critical decision making.

Required Qualifications

  • Bachelor’s degree in Life Science, Engineering, or closely related discipline; Or an equivalent combination of education and work experience.

  • Minimum 5 years' experience in quality or related field. Less experience may be appropriate with an advanced degree.

Preferred Qualifications

  • Experience with external inspections e.g., FDA, Notified Bodies

  • Experience working with Data Analytics to generate metrics, e.g., PowerBI.

  • Excellent organizational skills – must be able to manage multiple projects.

  • Attention to detail – must have precision in their work, especially as it relates to understanding and documenting complex quality issues.

  • Excellent writing skills – must be able to summarize complex issues in a clear, succinct, and accurate manner. Must be able to write in a manner that effectively conveys complex issues to the reader.

  • Effective interpersonal skills – Work with peers throughout the organization and be effective in engaging resources throughout the organization.

  • Excellent critical analytical skills – ability to find root cause of why an issue occurred. Ability to review action plans and determine if the actions taken effectively address the issue.

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

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, 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

$83,000.00 – $166,000.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Operations Quality

     

DIVISION:
TM Transfusion Medicine

        

LOCATION:
United States > Abbott Park : AP08B

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:
Standard

     

TRAVEL:
Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:
Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Lift, carry, push or pull weights of more than 20 pounds/9 kilos on a regular/daily basis, Work requiring repeated bending, stooping, squatting or kneeling

     

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf ID:uDnQdo