Quality Compliance Specialist (Change Controls)

Role: Quality Compliance Specialist focusing on change control activities within a biopharma cGMP environment. Responsibilities: review, assess, and approve change control documentation ensuring compliance with quality, regulatory, and SOP standards; facilitate cross-functional meetings and guide change owners; partner with QA colleagues and system users to enhance change control systems and procedures; interpret compliance/regulatory requirements for system implementation; support audits as a subject matter expert; leverage knowledge of biotech/pharmaceutical quality systems, FDA regulations, ICH guidelines, and global standards. Requirements: B.S. in life sciences or related field (or equivalent experience); 0-2+ years for Associate level, 2+ years for Specialist; proficiency in MS Word, Excel, PowerPoint; experience with Veeva/QMS a plus. High-Value: focus on internal change controls, cGMP compliance, FDA and international regulations, biotech/pharma quality systems, with the position based in Rensselaer, NY, working Monday-Friday, 8am-4:30pm. Collaboration: partner with QA and system end users; support audits and continuous improvement initiatives.