Quality Specialist

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:

Quality Specialist

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

The position of Quality Assurance Specialist is within our Toxicology Business Unit in Lake Forest, IL. This role will support site QA activities and primarily focus on one or more key quality subsystems, including document control, training, complaints, nonconformances, CAPA and/or supplier control. 

What You’ll Work On

• Responsible for implementing and maintaining the effectiveness of the Quality System.

• Participate in Quality System processes which may include training, corrective action and preventive action (CAPA) activities, change control, document control and general QMS administrative support.

• Aid in implementing process improvements with respect to Quality Assurance processes.

• Maintain Quality metrics as required.

• Provide support to QA activities for regulatory compliance (i.e. Management Review support, regulatory audits).

• Assist in determining quality attributes and requirements. May provide technical assistance.

• Utilize quality management techniques to perform investigations and facilitate solutions.

• Work with managers to coordinate training requirements for employees as required.

• Manage training program and organizational chart as needed.

• Review/approve supplier surveys and make recommendations as required.

• Assist with internal audits and agency audits.

• Manage Document Control as required.

• Drives functional performance to ensure that cross-functional standards and expectations are met.

• Responsible for completing documentation in a timely manner and in accordance with business standards.

• 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.

• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.

• Carries out duties in compliance with established business policies.

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

• Perform other duties and projects as assigned.

Required Qualification

• BS/BA degree in chemistry, biology, or other scientific discipline or equivalent combination of education and work experience

• 1-3 years’ experience in Quality Assurance or Regulatory Compliance experience in a manufacturing environment, preferably in vitro diagnostics

• Writing and Communication Skil