Specialist, Incoming QA
Core
Ensuring compliance and quality release of incoming raw materials, single-use assemblies, and bulk drug substances for biologics manufacturing.
Role type
Incoming Quality Assurance Compliance Specialist
Builds
Compliant drug products for marketed and investigational use
Domain
Biopharmaceuticals / Biologics / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, regulatory requirements knowledge, quality oversight, investigation leading, specification authoring, SOP auditing, stability program support, continuous improvement
Preferred skills
None stated
Technologies
None stated
Responsibilities
Release incoming raw materials and bulk drug substances, oversee excipient sampling, lead investigations on specification results, audit release records, author specifications and SOPs, act as SME during inspections, support stability programs, maintain finished product status, administer quality logs
Seniority
Mid-level, hands-on IC