Quality Assurance Officer
Core
Plan, execute, and report audits for the organization, subcontractors, and suppliers to ensure compliance with internal SOPs and bioanalytical method validation guidelines (FDA, EMA). Review raw data against draft reports to verify accuracy and completeness, and monitor the implementation of corrective measures.
Role type
Quality Assurance Officer
Builds
Compliance with regulatory standards (FDA, EMA, GCLP, GCP, GMP, ISO17025, ISO15189) and internal quality procedures.
Domain
Life Sciences / Bioanalytical Testing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Audit planning and execution, Raw data review, CAPA evaluation, Procedure development and review, Quality training delivery, Regulatory guideline knowledge (GCLP, GCP, GMP, ISO standards)
Preferred skills
Analytical skills, Process optimization, Organizational talent, Pressure management
Technologies
GCLP, GCP, GMP, ISO17025, ISO15189
Responsibilities
Plan and execute protocol, laboratory, and data audits; Review raw data against draft reports; Monitor corrective measures; Prepare and improve QA procedures; Host client audits and regulatory inspections; Evaluate CAPA reports.
Seniority
Mid-level, hands-on IC
