Main Purpose of Job
* This is an individual contributor role with expectations aligned to the Capabilities and Behaviours as set out in the Abbott Dundee Employee Handbook.
* Working as part of the Product Support Team, the Coordinator, CAPA is primarily responsible for providing ownership, oversight and reporting of Nonconformance and Corrective and Preventive Action (CAPA) processes at Abbott Dundee.
Accountabilities
* Ownership of the Nonconformance and Corrective and Preventive Action (CAPA) System.
* Assist in the initiation, processing and completion of QI/CAPA records in the electronic system.
* Ensuring record owners are assigned, and timely responses and approvals are provided in alignment with quality goals.
* Assessing and documenting the impact of each Nonconformance event to determine the requirement and extent of investigation.
* Lead meetings and communications for QI/CAPA updates, information, and concerns, including chairing site CAPA Review board. Communicate confidently and effectively with all levels of management, peers and key stakeholders, including timely escalation of quality issues.
* Responsible for collation of metrics and reporting on regular basis in accordance with established procedures.
* Support team in the delivery and oversight of CAPA training program.
* Provide support and subject matter expertise during audits and inspections.
* Lead and/or contribute to continuous improvement initiatives and projects.
* Taking a self-motivated approach to continuous professional development and engaging with site training initiatives.
* Being aware of the policies as set out in the Abbott Employee Handbook and able to enact them as appropriate
* Carries out other duties as and when requested by Line and or Department Manager
Base Requirements
* Degree or equivalent, preferably a life science subject area, and/or
* Experience in a regulated industry preferred.
* Experience with a range of root cause investigations tools and techniques.
* Competence with QI/CAPA processes
Background
* A practical understanding of immunoassay and clinical chemistry testing, In-vitro Diagnostics (preferred)
* Experience with an Enterprise Resource Planning System (ERP)
* Experience with Electronic Document Management Systems (EDMS)
* Experience with QI/CAPA Systems (Agile preferred)
* Experience with Complaint Investigation systems (Helix preferred)
* Proficient with MS Word, Excel and Power-Point.
#J-18808-Ljbffr