QA Compliance Specialist
Core
Administer, review, and coordinate Change Control records to ensure compliance with company procedures and regulatory requirements in a biologics manufacturing environment.
Role type
QA Compliance Specialist
Builds
Quality System documentation and regulatory compliance for biologics medicines
Domain
Pharmaceutical/Biotechnology manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Change Control management, Deviation investigations, CAPA management, Risk assessment, Quality System documentation review, Regulatory compliance (cGMP), Stakeholder coordination
Preferred skills
Biologics manufacturing experience
Technologies
Quality Management Systems (QMS), Change Control software
Responsibilities
Support administration and coordination of Change Control records; Provide quality oversight of Change Control activities throughout the lifecycle; Review and approve Quality System documentation including SOPs and Work Instructions; Collaborate with Manufacturing, QC, Engineering, and Supply Chain; Monitor open records and escalate risks; Generate and trend Quality System metrics; Participate in investigations and support corrective actions; Deliver training on Quality System processes.
Seniority
Mid-level, hands-on IC