QA Specialist II
Core
Ensure compliance with GMP standards, FDA regulations, and international quality requirements while supporting manufacturing operations across multiple product lines.
Role type
Quality Specialist II (Pharmaceutical/Biotech Manufacturing)
Builds
Quality management systems and compliant manufacturing operations
Domain
Pharmaceutical/Biotech Manufacturing
Required skills
GMP compliance, FDA regulations, ISO standards, quality management systems, batch release, complaint management, deviation investigations, CAPA, change control, root cause analysis, internal audits, regulatory inspections, cleanroom procedures, technical writing, analytical problem-solving
Preferred skills
Biology, Chemistry, Engineering, Life Sciences
Technologies
TrackWise, Master Control, Microsoft Office
Responsibilities
Implement continuous improvement initiatives, conduct investigations, maintain quality management systems, support external regulatory inspections, conduct internal audits, manage batch release and complaints
Seniority
Mid-level, hands-on IC
