Job Description: Quality Assurance Specialist at Abbott Nutrition
Company Overview:
Abbott is a global healthcare leader dedicated to helping people live more fully at all stages of life. Our diverse portfolio includes diagnostics, medical devices, nutritionals, and branded generic medicines. With over 113,000 employees, we serve people in more than 160 countries.
In Ireland, Abbott employs around 6,000 people across ten sites, including manufacturing facilities in Clonmel, Cootehill, Donegal, Longford, Kilkenny, and Sligo, as well as support operations in Dublin and Galway. Abbott has been operating in Ireland since 1946.
Abbott Ireland Nutrition Division - Cootehill, Cavan:
Our Cootehill facility produces infant formulae under the "Similac" brand and follow-on formulas under "Gain." The plant processes liquid skim milk combined with carbohydrates, vegetable oils, vitamins, and minerals, which are blended, pasteurized, dried, and packaged for distribution worldwide.
Purpose of the Job:
* Review all Quality Records (QRs), providing leadership and direction for QR initiation and root cause analysis.
* Ensure site Quality CAPA Metrics are recorded and reported as needed.
Major Responsibilities:
* Conduct regular CAPA meetings to track timelines and quality of QRs and related actions.
* Lead and support the Corrective and Preventative Action System across the plant.
* Verify and report on site Quality CAPA metrics monthly.
* Train site personnel on CAPA requirements as guided by division/corporate policies.
* Review site QRs for compliance with Rubric and policy requirements.
* Prepare CAPA reports for management review and area-specific information.
* Manage unexpected manufacturing events, including containment and sampling if necessary.
* Review global CAPA impacts and support escalation processes.
* Support the QA CAPA IT System (ABTRAQ) and develop plant SME capabilities.
* Participate in community of practice meetings and internal audits, including compliance walkdowns.
Education & Competencies:
Diploma or Degree in science or engineering, with at least three years of manufacturing experience in a quality assurance role within a regulated environment.
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