Quality Assurance Associate

Reporting to the Director of Quality Assurance, the Quality Assurance (QA) Associate is responsible for conducting and reporting quality assurance audits and reviews as scheduled. The QA Associate supports the QA department in assessing compliance of clinical and non-clinical studies with applicable regulations, guidelines, study protocols, study plans and company SOPs. Responsibilities Perform audits of company facility and studies for compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Standard Operating Procedures (SOPs), study protocols, pertinent regulations and guidelines (FDA, Health Canada, EMEA, etc.); Perform inspections of Bioanalytical studies, for compliance with the OECD Principles of Good Laboratory Practices, Study Plans and Standard Operating Procedures (SOPs) at the critical phases of the studies; Review Workplans, Study plans, CAPAs, Change Controls/Implementations, SOPs; Audit pre-study documentation, in-process activities, end-of-study documentation and study reports; Conduct various facility audits, including audits of equipment maintenance, training records, computer validation and vendor qualification; Keep Management up to date with findings and follow up on corrective actions; Assist in the review, writing and distribution of SOPs, as applicable; Assist QA management in hosting sponsor and regulatory audits/inspections; Assist QA department in the training of personnel on SOPs and GCPs/GLPs. Coordinate and interact with other departments to ensure corporate, departmental and study goals are met.

CellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics, and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The Company operates globally with facilities located in Canada, USA, Belgium, Australia, and China.