Quality Assurance Specialist

5 hours ago

Lake Forest, California, United States Abbott Full time
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.

Job Summary

We are seeking a Quality Assurance Specialist to join 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
  • Implement and maintain the effectiveness of the Quality System.
  • Participate in Quality System processes, including 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, including Management Review support and regulatory audits.
  • Assist in determining quality attributes and requirements.
  • 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 and approve supplier surveys and make recommendations as required.
  • Assist with internal audits and agency audits.
  • Manage Document Control as required.
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, including the ability to write technical reports and present data analysis.
  • Experience with MS Office, including Excel and PowerPoint.
  • Must be detail-oriented, self-motivated and available for flexible scheduling.
Preferred Qualifications
  • Experience with electronic document control systems.
  • Knowledgeable of federal and other regulations, including QSR's, ISO, ISO 13485, and CMDR.
  • Demonstrated initiative and problem-solving skills.
  • Ability to use various types of databases and other computer software.
  • Strong organizational skills.
  • Ability to clearly, concisely and accurately convey communications.
  • Knowledge of quality management techniques and application.
  • Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor.

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