Drug Product Quality Assurance Specialist
Core
Provides quality oversight to aseptic Drug Product manufacturing and inspection areas, ensuring adherence to cGMP and regulatory expectations.
Role type
Drug Product Quality Assurance Specialist
Builds
Safe, compliant, and reliable pharmaceutical manufacturing operations
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, deviation investigations, root cause analysis, CAPA management, change control, risk assessment, document review and approval, regulatory inspection coordination, process and product validation oversight
Preferred skills
Aseptic processing experience, contamination control strategies, environmental monitoring, utility monitoring systems, project management, cross-functional team leadership
Technologies
Quality Management Systems (QMS), GMP documentation tools
Responsibilities
Partner with Manufacturing and Engineering to facilitate root cause analyses, risk assessments, and CAPAs; Provide quality oversight for deviations, change controls, and CAPAs; Ensure operations align with GMP, safety, and controls regulations; Participate in internal/external audits and interact with regulatory agencies; Review and approve controlled documents like SOPs and protocols; Drive continuous improvement and digital innovation projects
Seniority
Mid-level IC, hands-on execution with some oversight
