Quality Assurance Specialist

3 weeks ago


Lake Forest, California, United States Abbott Full time

About the Role:

The Quality Assurance Specialist will be responsible for implementing and maintaining the effectiveness of the Quality System 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.

Key Responsibilities:

  • 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.

Requirements:

  • 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 Skills (e.g. write technical reports, present data analysis).
  • Experience with MS Office including excel and power point.
  • Must be detail-orientated, self-motivated and available for flexible scheduling.

About Abbott:

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. 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.

We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call or email.



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