Senior Specialist, Quality Assurance (Hybrid)
Core
Independent approval of documentation and batch release decisions for clinical supply API manufacture, testing, and release to ensure compliance with GMP and regulatory requirements.
Role type
Senior Specialist, Quality Assurance (Clinical Supply API)
Builds
Clinical supply programs for API manufacture and testing
Domain
Pharmaceutical industry, Clinical Supply, Good Manufacturing Practice (GMP)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP Auditing, Deviation Management, Data Analysis, Project Management, Technical Writing, SOP Development, Quality Risk Management, CAPA Management, Systematic Problem Solving, Compliance Auditing
Preferred skills
Small molecule API knowledge, R&D or clinical supply process experience, Veeva/SAP system knowledge
Responsibilities
Review and approve GMP documents and batch records for product release; Conduct independent audits of batch documentation, data, and facilities; Establish and update Standard Operating Procedures (SOPs); Support compliance activities including site readiness, inspections, and CAPAs; Facilitate quality risk management activities; Analyze data to support quality system metrics.
Seniority
Senior, hands-on IC
