Quality Specialist II - Complaints
Core
Ensure compliance with GMP standards, FDA regulations, and international quality requirements while supporting manufacturing operations and maintaining quality management systems.
Role type
Quality Specialist II (pharmaceutical/biotech manufacturing)
Builds
Quality management systems and regulatory compliance for global healthcare and scientific products
Domain
Pharmaceutical/Biotech Manufacturing
Required skills
GMP regulations knowledge, deviation investigations, CAPA, change control, root cause analysis, quality management systems, internal audits, regulatory inspections, technical writing, analytical problem-solving
Preferred skills
Biology/Chemistry/Engineering/Life Sciences background, TrackWise/Master Control experience, cleanroom gowning procedures, project management
Technologies
TrackWise, Master Control, Microsoft Office
Responsibilities
Conduct deviation investigations and root cause analysis, maintain quality management systems, support internal audits and external regulatory inspections, implement continuous improvement initiatives, ensure compliance with FDA and international regulations
Seniority
Mid-level, hands-on IC
