Sr Quality Systems Engineer

Role: Quality Systems Specialist supporting pharmaceutical quality management systems at a biotech manufacturing site. Primary objectives include ensuring compliance with CGMP, facilitating change control, document management, and continuous improvement initiatives. Responsibilities encompass overseeing change management activities, managing quality records, participating in inspections/audits, and supporting regulatory compliance across manufacturing operations. Requirements: Bachelor's degree in a scientific discipline (biology, chemistry, or related), with at least 7 years of industry experience and 3+ years in Pharmaceutical QA. Preferred experience includes manufacturing of dosage forms, health authority inspections (FDA, EMA), and project management skills. High-Value: GMP compliance, change control, document management, pharmaceutical manufacturing, site audits, and cross-functional collaboration with Operations, MLT, R&D, and Supply Chain. Work setup: On-site at Salt Lake City, UT; physical activity includes sitting, light lifting, and PPE use in production areas.