Jobs at Caprion Biosciences

Individual contributor responsible for quality assurance in a regulated environment. Leads client audits and regulatory inspections, presents the QMS, coordinates responses and CAPA activities, and reviews quality documentation, deviations, complaints, investigations, and change controls. Supports internal audits, supplier qualification, computerized system validation, equipment lifecycle management, quality metrics, risk management, training, and continuous improvement.

Leads the development and sustainability of CellCarta’s Quality Management System and supplier quality program. Responsibilities include harmonizing procedures, analyzing quality data, coordinating document control, qualifying and auditing suppliers, managing quality agreements and corrective actions, supporting third-party vendor management, and contributing quality oversight throughout software development projects. The role also supports ISO certification audits and serves as a QMS subject matter expert.

Leads the development, harmonization, and sustainability of CellCarta’s Quality Management System and Supplier Quality Program. Responsibilities include quality data reporting, document control, supplier classification and audits, quality agreements, corrective action management, approved supplier oversight, vendor management, and quality support throughout software development lifecycles. The role also supports ISO certification audits and serves as a QMS subject matter expert while ensuring compliance with GCLP, GMP, ISO, CAP, CLIA, and global regulatory requirements.

Dirige et soutient le système de gestion de la qualité et le programme de qualité des fournisseurs. Le poste comprend l’harmonisation des procédures, l’analyse des données qualité, le contrôle documentaire, la qualification et l’audit des fournisseurs, la gestion des SCAR et des accords qualité, ainsi que le soutien aux projets logiciels et aux audits ISO. La personne contribue également à la conformité réglementaire mondiale et doit maîtriser le français et l’anglais.

Supervise histopathology laboratory operations, including tissue processing, embedding, sectioning, blood processing, and specialized staining. Lead, train, and assess laboratory staff; maintain GxP, CAP, CLIA, SOP, safety, equipment, inventory, and audit compliance. Support process improvements, equipment qualification, tissue bank maintenance, and cross-functional operational excellence while performing bench work as needed.

Supports assay operations, optimization, validation, troubleshooting, technical training, equipment maintenance, and laboratory process improvement. Performs histochemical, immunohistochemical, and in situ hybridization assays, prepares reagents, maintains records, manages protocols, supports assay transfers, tissue inventory, audits, and regulatory compliance. Serves as a technical resource for laboratory teams, project managers, clients, and auditors while ensuring accurate, high-quality clinical, non-clinical, and research testing.

Supports clinical study conduct and setup through sample review, query management, shipment requests, data entry, documentation, reporting, audits, and study closure. Maintains study information in StarLIMS and customer systems, prepares workflows and quality controls, supports testing release, and assists Project Managers with administrative coordination. Participates in process improvement while ensuring projects remain on task, on track, and on time.

Supports senior project managers in planning and coordinating preclinical and clinical trial projects from initiation through closeout. Tracks schedules, budgets, samples, documentation, risks, deviations, CAPA actions, data quality, and client reporting. Coordinates laboratory workflows, slide QC, testing schedules, system configurations, change orders, secure data transfers, kickoff meetings, and sponsor communications while maintaining audit readiness and compliance with protocols and SOPs.

Supports operational execution of oncology clinical trials by managing site regulatory documents, monitoring visits, action items, site activation, close-out activities, and audit readiness. Coordinates with Project Management, Regulatory Affairs, and Quality Assurance; maintains eTMF and CTMS documentation, manages trial-system access, tracks protocol amendments and informed consent forms, and maintains compliance dashboards.

Supports oncology clinical trial operations by overseeing site regulatory documentation, monitoring visit reports, action item resolution, site activation and close-out activities. Coordinates with Regulatory Affairs, Quality Assurance, and Project Management; manages essential document collection, eTMF readiness, system access, regulatory packages, protocol amendments, and compliance dashboards. Requires strong organization, attention to detail, and full-time onsite attendance.

Develop, validate, and operate bioinformatics pipelines and software for genomics services. Build ETL and data integration workflows, support cloud infrastructure, ensure CSV and QMS compliance, troubleshoot pipelines, and train users while meeting project timelines and quality standards.