Quality Assurance Specialist II

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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 109,000 colleagues serve people in more than 160 countries.

About Abbott

Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions.

Abbott's life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.

The position of Quality Assurance Specialist II is within our Toxicology Business Unit located in Pomona, California. This role will primarily be focused on performing customer complaint investigation and write report; execute verification or validation protocols and reports. Test and analysis of products. Generate or revise QC related documents as needed.

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WHAT YOU'LL DO

  • Aid in implementing process improvements with respect to Quality Assurance processes
  • Maintain Quality metrics as required
  • Manage and/or assist with complaints, CAPA, change requests, NCMRs, deviations
  • Provide support to QA activities for regulatory compliance, (i.e. Management Review support, regulatory audits)
  • Work with managers to coordinate training requirements for employees as required
  • Manage training program and organizational chart as required
  • Perform Quality System Training Requirements as needed
  • Review/approve supplier surveys and make recommendations as required
  • Assist with internal audits and agency audits
  • Manage Document Control as required
  • Manage equipment maintenance and calibration program as required
  • Assist with equipment, process and facility qualification and validation activities as required
  • Release lots to Production
  • Review Raw Material Specification QC Forms
  • Mentor and train junior level associates
  • 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. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
  • Carries out duties in compliance with established business policies
  • Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies
  • Perform other duties and projects as assigned


EDUCATION AND EXPERIENCE YOU'LL BRING

Required:
  • BS/BA degree or equivalent in chemistry, biology, or other scientific discipline
  • Minimum of two-five years' experience in Quality Assurance or Regulatory Compliance experience in a manufacturing environment, preferably in vitro diagnostics or FDA regulated industry with 1-3 years of progressively responsible positions.


Preferred:
  • Knowledgeable of federal and other regulations, e.g. QSR's, ISO, ISO 13485, CMDR
  • Experience with 21 CFR 820, ISO 13485
  • Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor
  • Goal oriented, learns quickly, works in a collaborative manner with other departments.
  • Strong writing and verbal communication skills.
  • Must be detail-orientated, self-motivated and available for flexible scheduling
  • Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio


WHAT WE OFFER:

At Abbott, you can have a good job that can grow into a great career. We offer:

  • Training and career development , with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a generous company match
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities


Learn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspx

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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.

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