Senior Quality Specialist
Core
Ensures quality compliance and drives system improvements within laboratory operations and technical groups.
Role type
Senior Quality Specialist (Laboratory)
Builds
Laboratory operations and technical group processes
Domain
Life sciences / Pharmaceutical testing / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP/GLP/ISO IEC 17025 compliance, internal audit execution, SOP review and approval, data review (analytical/validation/investigations), non-conformance analysis, root cause analysis, technical writing, regulatory interpretation, system improvement identification, computer program change implementation
Preferred skills
Scientific orientation, organizational skills, ability to work independently and in teams, adaptability, self-motivation
Technologies
Spreadsheets, PowerPoint, databases, computer programs
Responsibilities
Perform internal quality assurance audits, review client/agency documents and communicate requirements to technical operations, review and approve SOPs, perform data review for compliance and identify issues, investigate and document QA/method/regulatory deficiencies, implement and document computer program changes
Seniority
Senior, hands-on IC
