QA Specialist

Job description

QA Specialist Location: College Park, Dublin: Reports To: QA Manager: About the Role: We’re looking for a QA Specialist to join our Bulk Drug Substance (BDS) facility at ADMF, where you’ll provide end‑to‑end quality oversight across manufacturing, testing, documentation, and product disposition. This is a high‑impact role at the heart of our biologics operation — ensuring every batch we produce is safe, compliant, and ready for patients who rely on us. You’ll be a key partner to Operations, QC, Engineering, Supply Chain and QPs, helping maintain a robust Quality Management System and supporting inspection readiness across the site. If you thrive in a fast‑paced, highly regulated environment and want to make a meaningful difference, this is the place to do it. What You’ll Do: - Provide quality and cGMP oversight for all commercial manufacturing activities in the BDS facility. - Review and approve executed and master batch records, including electronic batch record recipes. - Review and approve technical documentation such as cleaning, process, and method validation. - Review and approve SOPs, work instructions, technical reports, and protocols. - Participate in and provide QA oversi...