Quality Specialist II
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, deviation investigations, CAPA, change control, and root cause analysis for global healthcare and scientific products.
Domain
Pharmaceutical/Biotech Manufacturing, Quality Assurance
Required skills
cGMP regulations knowledge, ISO standards (9001/13485), quality management systems (TrackWise, Master Control, Documentum), deviation investigations, CAPA, change control, root cause analysis, technical writing, analytical problem-solving, internal/external audit support, project management, PPE adherence, cold environment work, cryogenic material handling.
Preferred skills
Biology, Chemistry, Engineering, or Life Sciences background.
Technologies
TrackWise, Master Control, Documentum, Microsoft Office suite.
Responsibilities
Implement continuous improvement initiatives, conduct investigations, maintain quality management systems, support internal audits and external regulatory inspections, work in warehouse environments with gowning procedures, handle frozen materials using dry ice or liquid nitrogen.
Seniority
Mid-level (2+ years experience)
