LabConnect

The Quality Audit Specialist executes internal and external audits while monitoring GCP regulatory compliance across clinical trial operations. They also manage document control activities, track quality metrics, and support continuous improvement initiatives within the electronic Quality Management System.

Support the Global Sample Processing Network (GSPN) through project initiation, protocol development, and laboratory capability assessments. Act as a technical liaison between clients and laboratories while monitoring KPI metrics to ensure compliance and performance standards.

Provide project management oversight for biopharmaceutical clients, managing analytical testing, method development, and validation under GLP. Lead vendor contracting, coordinate study documents, and ensure accurate data transfer and sample logistics.

Lead the design and implementation of robust bioanalytical strategies for pharmaceutical and biotech clients. Act as a Subject Matter Expert in regulated bioanalysis, authoring regulatory documents and interacting with Health Authorities to mitigate risk.

Drive the end-to-end biospecimen lifecycle management from receipt to final disposition and ensure accurate metadata for clinical studies. Manage project plans, data transfer with laboratories, and provide technical guidance to junior personnel.