Specialist QA
Core
Lead investigations, approve validation protocols and change controls, and manage site quality programs for pharmaceutical and biotechnology manufacturing.
Role type
Senior IC Quality Assurance Specialist
Builds
Validated manufacturing processes and compliant product lots
Domain
Pharmaceutical/Biotechnology Quality Assurance (via careerplan.io/jobs/13d7254f-6c4a-4d46-8cc5-8545624bec39-specialist-qa-at-echo-consulting-group)
Required skills
Quality Assurance, Process Validation, Change Control Management, CAPA, Root Cause Analysis, Regulatory Compliance, Risk Assessment, Audit Management, Lot Disposition, Incident Triage
Preferred skills
Biopharmaceutical industry experience, Cross-functional team leadership, Regulatory agency interaction, Data trending and evaluation
Technologies
EMS/BMS systems, Work Order systems, Database applications
Responsibilities
Lead investigations, Approve process validation protocols and reports, Approve change controls, Lead site audits, Provide lot disposition, Review Risk Assessments, Represent QA on NPI team, Request Quality on incident triage team
Seniority
Senior, hands-on IC
