Sr. QA Specialist - Pharmaceutical Manufacturing

Role: QA Specialist at a GMP biologics manufacturing site, responsible for ensuring compliance of biologic products with quality standards and regulations. Responsibilities: review and approve manufacturing and support documentation, lead deviation assessments, validate processes, and support quality improvement initiatives; train and mentor QA team members; collaborate with Manufacturing and QC teams to resolve quality issues and audits. Requirements: Bachelor's in science or related field; 10+ years QA experience in pharmaceutical/biologics GMP manufacturing; strong knowledge of GMP, validation, deviation handling, and CAPA processes; excellent communication and stakeholder management skills. Preferred: Master's degree; 6+ years QA leadership experience. High-Value: biologics (hemophilia, growth hormone), GMP manufacturing, site compliance, deviation and validation review, cross-functional collaboration, onsite role in New Hampshire with minimal travel. WorkSetup: onsite, Monday-Friday, within a 24/7 GMP facility.