Quality Assurance Specialist I
Core
Support Manufacturing Investigations and Corrective and Preventive Actions (CAPA) to ensure compliance and quality in GMP manufacturing operations.
Role type
Quality Assurance Specialist I (GMP Manufacturing)
Builds
Inhalation drug products (spray dry dispersion and dry powder inhaler capsules) for clinical development through commercial launch.
Domain
Pharmaceutical manufacturing (GMP)
Required skills
GMP knowledge, batch record review, CAPA support, raw material sampling coordination, environmental monitoring support, compliance inspection support, Microsoft Office proficiency
Preferred skills
None stated
Technologies
Microsoft Office Suite
Responsibilities
Perform real-time review of production activities including area clearance and batch records; Support raw material sampling and coordinate material release; Review and approve Materials Management activities; Support Environmental Monitoring Program; Provide support during compliance inspections; Support GMP manufacturing shifts and floor meetings
Seniority
Junior, entry-level specialist
