Senior Specialist, Quality Assurance
Core
Ensuring quality and compliance of GMP computerized systems and supporting infrastructure across manufacturing, packaging, labeling, and laboratories to protect product quality and patient safety.
Role type
Senior Specialist, Digital and Data Quality (Quality Assurance)
Builds
Validated computerized systems and quality oversight for GxP business processes
Domain
Pharmaceutical manufacturing / Computerized System Validation (CSV)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer System Validation (CSV), GMP Compliance, Data Integrity, Regulatory Compliance (21 CFR Part 11, 210, 211, 820), Quality Auditing, System Health Monitoring, Disaster Recovery Planning, Technical Writing, Project Management, Data Analysis
Preferred skills
Six Sigma, PMP, Change Management, GAMP, Coaching
Technologies
GxP systems, automated manufacturing equipment, automated lab systems, IT infrastructure
Responsibilities
Assess and remediate legacy systems; provide independent quality approval of validation documentation; ensure Operating Level Procedures are followed; support regulatory inspections and audit activities; drive resolution of regulatory non-conformances; mentor junior team members
Seniority
Senior, hands-on IC with limited supervision