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Quality Assurance Supervisor

2 months ago

Columbus, Ohio, United States Abbott Laboratories Full time
About Abbott Laboratories

Abbott Laboratories 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.

We're always looking towards the future, anticipating changes in medical science and technology. Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active.

Working at Abbott Laboratories

At Abbott Laboratories, 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:

  • 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, with medical benefits starting on day one
  • Vacation – 3 weeks accrued vacation (1st year is prorated) + vacation buy program + 3 personal days + 10 paid holidays
  • 401(k) retirement savings with a generous company match of 5%
  • 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 stability of a company with a record of strong financial performance and history of being actively involved in local communities
The Opportunity

This position works out of our Columbus, OH location in the Nutrition Division.

Main Responsibilities
  • Implement and maintain an effective Quality System within the Third-Party Manufacturing organization
  • Implement and maintain an effective release process for Third Party Manufacturing and Warehouse sites, managing the batch release team
  • Act as liaison with other departments on behalf of the Third-Party Manufacturing organization
  • Provide direction, support, leadership, and management of compliance to Federal Regulations, International Standards/Directives, or other applicable governing bodies and Abbott Policies as they relate to audits, quality systems, manufacturing, manufacturing support, and CAPA management
  • Manage, lead, and develop individuals who can continually support a compliant environment
Requirements
  • Bachelor's Degree or equivalent combination of education and work experience
  • Minimum 2 years Regulatory, Compliance, or Auditing experience
  • Minimum 3 years Quality Assurance experience
What You'll Work On
  • Exercise independent, expert judgment to provide direction and management to all departments regarding risk and resolution
  • Serve as a strategic player, achieve a balance of involvement and objectivity, and prioritize for GMP compliance
  • Provide technical support as the area subject matter expert for Quality System/Compliance/Regulatory processes, procedures, and issues, keeping current with regulatory requirements, proposals, and best practices via constant surveillance of governmental publications, attending GMP/FDA seminars and meetings, and disseminating regulatory requirements to appropriate personnel
  • Perform impact assessments on procedures and processes that are within or impact the Third-Party Manufacturing organization
  • Provide feedback (or direction), formulating recommendations, and determining if corrective actions and commitments have been properly implemented and are effective
  • Monitoring metrics through Continuous Improvement Meetings, Annual Product Reviews, and Quarterly Management Review Boards and weekly and monthly reports
  • Participate in or lead internal and external site audits as required
  • Coordinate and chair Quarterly Management Reviews to ensure the quality management system is suitable, adequate, and effective to meet the regulatory requirements and to support the established quality policies and objectives
  • Lead, develop, and coach Quality System team, with direct reports (3)