SEPTODONT - Quality Assurance Project Associate

Maintains and creates client‑specific quality documentation, including quality plans, failure modes and effects analyses (FMEA), and medical device records, as well as tracking commitments, organizing correspondence, and creating and maintaining project files.Provides administrative support to the QA project team during new product introductions, technical transfers, and ongoing client projects.Communicates regularly with Pharma clients through the preparation and sending of client notifications for quality events (e.g., deviations, investigations, change controls). Coordinates routine and ad‑hoc quality discussions with clients, providing status updates, clarifying requirements, and ensuring that client questions are addressed promptly and accurately Discussions require sound judgement and professional discretion that uphold regulatory expectations and protect product quality. Participates in client meetings as the QA representative.  Relays information to QA leadership including client escalations or leadership input, direction and/or decision making.Tracks client acknowledgments, responses, and follow‑up actions to ensure timely closure and proper documentation.  Tracks notification timing for compliance reporting to QA leadership; escalates deviations based on contractual requirements.Supports client regulatory filing activities by obtaining and preparing documentation required for related filings.  Sends documentation (with relevant redactions) to clients and/or direct to regulatory agencies as part of client product submissions.Reviews and releases development pharma batches, determining batch status, e.g., release, reject, or product hold for further clarification or investigation.  Serves as the decision-making authority, bearing accountability and responsibility for verifying compliance and authorizing release.Reviews and releases commercial pharma batches during peak manufacturing times as required, determining batch status, e.g., release, reject, or product hold for further clarification or investigation.  Assesses potential impact of incidents and processing deviations on the quality and suitability of the product for release to clients. Serves as the decision-making authority, bearing accountability and responsibility for verifying compliance and authorizing release.Tracks quality deliverables and timelines, ensuring documents are routed, reviewed, and approved on schedule to meet project timelines.  Drives completion of quality documentation through routine follow-up and communication with internal stakeholders and external clients.Assists in compiling quality metrics, reports, and project summaries for internal and client use.Identifies opportunities to streamline documentation workflows and improve the efficiency of QA project processes.Participates in departmental initiatives aimed at strengthening quality compliance and operational consistency.Coordinates meetings, prepares agendas, and documents minutes.