The Specialist, Quality Assurance position supports the investigation process, customer complaints and Annual Product Reviews (APR); through the quality review and approval of technical documents and investigations (laboratory, manufacturing, packaging and storage) associated with Investigation Reports (IR), Customer Complaints, and associated Corrective Action Preventive Action (CAPA). With regard to the site investigation process, the individual will: (a) provide quality, compliance and technical feedback with regard to the investigations, (b) will approve investigations on behalf of QA (when thorough and complete), and (c) will issue Action items and / or CAPAS as applicable to the investigation / complaint. Additional responsibilities will include supporting the generation of APRs and the review of APRs prior to internal circulation for Halo approval. Responsibilities will include supporting the trending associated with IRs, Complaints, Key Process Indicators (KPIs) and / or other Quality Metrics associated with the TrackWise Investigation Process.
Ancillary responsibilities include supporting regulatory and customer audits; as well as interacting with the customer to resolve / mitigate issues and concerns related to investigations and corrective action.