Specialist I, Quality Assurance
Core
Quality Specialist supporting clinical trial projects by ensuring compliance with regulatory requirements, GMP, and SOPs while maintaining accurate documentation.
Role type
Specialist I, Quality Assurance (GMP Manufacturing)
Builds
Clinical trial supplies and drug delivery products
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, SOP adherence, documentation management, continuous improvement, data accuracy, regulatory compliance
Preferred skills
Aberrant data identification, compliance concern escalation, deadline management
Technologies
None stated
Responsibilities
Participate in continuous improvement initiatives for quality management; Create Certificate of Analysis adhering to GMP standards; Support clinical trial projects for regulatory compliance; Implement and maintain quality assurance processes; Ensure accurate and up-to-date documentation
Seniority
Specialist I, entry-level to mid-level IC