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Quality Assurance Complaints Specialist

2 months ago

Tipp City, Ohio, United States Abbott Full time

The Opportunity

This role is situated within our Abbott Nutrition division. Our Nutrition sector is dedicated to creating scientifically-backed nutritional products for individuals across all life stages, from supporting the growth of infants and children to maintaining the vitality of adults. Our esteemed brands, including Similac, PediaSure, Pedialyte, Ensure, and Glucerna, are relied upon by millions globally to provide essential nutrients for a healthier lifestyle.

Our facilities are equipped with cutting-edge technology aimed at enhancing production efficiency and ensuring product quality. By joining our team, you will become part of a community committed to innovation and excellence, focused on nourishing families worldwide.

What You'll Work On

As the Quality Assurance Complaints Specialist, you will independently assess complaint documentation and investigation data to ascertain the necessity for further inquiry regarding potential product, labeling, or packaging discrepancies. You will perform final reviews of complaint cases and ensure that all documentation and procedures are correctly applied in a timely and uniform manner.

This position operates under the guidance of the Quality Systems Supervisor or Manager. Handling customer complaints is critical due to its high regulatory implications. Properly managed complaints can enhance customer loyalty, while mishandled complaints may lead to business loss, legal issues, negative media coverage, or product recalls. This role demands a keen attention to detail throughout the complaint handling process to mitigate risks of errors.

  • Complete all tasks related to the complaint process by established deadlines.
  • Input complaint investigation details into the Trackwise Complaint database, ensuring audit readiness.
  • Communicate effectively with Corporate, Division, and Operations/QA Management.
  • Collaborate with site Quality Systems, Compliance Manager, Sanitation Manager, Quality Engineers, and CAPA Coordinator.
  • Generate complaint data for site Quality Management Reviews/MBR.
  • Maintain records in accordance with Abbott's Record Retention policies.
  • Conduct batch record evaluations.
  • Coordinate investigations with cross-functional teams and Subject Matter Experts (SMEs).
  • Ensure timely evaluation and resolution of complaints.
  • Complete ABTRAQ investigations and CAPA-related projects pertinent to complaints.
  • Undertake special projects as requested by various organizational levels.
  • Adhere to all Abbott Nutrition policies and procedures.
  • Assist with additional Quality Systems tasks as necessary.

You will be responsible for upholding our compliance standards, including those set by regulatory bodies and Abbott's internal policies.

Required Qualifications

  • An Associate's degree in Business, Science, Technical Field, or a comparable combination of education and experience.
  • Strong organizational and prioritization skills.
  • Ability to adapt to urgent requests.
  • Excellent written and verbal communication skills, demonstrating strengths in core competencies.
  • Capacity to manage multiple tasks, drive results, and make independent business decisions.
  • Technical understanding of manufacturing processes related to batch processing, filling, and packaging.
  • Proficiency in various computer systems (e.g., Microsoft Office).

Preferred Qualifications

  • A minimum of 2 years of experience in Quality Assurance (e.g., Lab Analyst, Batch Log Auditor, or similar roles) is preferred.
  • Familiarity with the ABTRAQ CAPA system is advantageous.
  • Knowledge of general medical terminology is preferred.

In compliance with federal regulations, all candidates hired will be required to verify their identity and eligibility to work in the United States and complete the necessary employment eligibility verification form upon hire.