Quality Assurance Supervisor

Supports administrative function by acting as the Deputy Quality Assurance Manager in their absence, responsible for assigning Quality Assurance group tasks as workload requires, supervising training of Quality Assurance group on assigned training requirement, managing internal QA department documents, and serving as the primary contact for the PO system for the QA group. The role also involves monitoring Analytical Subcontractor compliance, writing, reviewing, and approving Events, CAPA, OOS/OOT and Change Control, managing investigations, and conducting Quality System, cGMP, and GLP training. Additionally, the position requires participation in data analysis and reporting, serving as QA trainer as needed, and supporting sister sites as required. The role supports all Quality Assurance I, II and III roles for data reporting, document control, and equipment control. Auditing responsibilities include performing Internal audits per Standard Operating Procedure, supporting and hosting client and regulatory audits, and conducting external audits. The position also supports Regulatory Compliance and the Stability Program by reviewing and approving Stability Protocols, reviewing Stability Chamber Pull Schedules, and monitoring Stability Chamber excursions. Furthermore, the role supports Manufacturing by executing and reviewing batch records, conducting quality assurance inspection and release of cGMP materials, and reviewing, creating, and approving Master Batch Records and Certificates of Compliance.