QA Officer
Core
Coordinate quality assessments on operational processes, execute audits, and verify bioanalytical study reports for compliance.
Role type
QA Officer (Quality Assurance Coordinator)
Builds
Compliance with internal procedures and bioanalytical method validation guidelines (FDA, EMA)
Domain
Life Sciences / Clinical Trials / Bioanalysis
Deliverable
client delivery
Required skills
Audit planning and execution, raw data review, CAPA evaluation, procedure development, training delivery, regulatory guideline knowledge (GCLP, GCP, GMP, ISO 17025, ISO 15189)
Preferred skills
Experience with ISO/IEC 17025 and 15189, Bachelor degree in Life Science or Quality-oriented education
Technologies
None stated
Responsibilities
Plan and execute audits according to timetable; Review raw data against draft reports; Monitor implementation of corrective measures; Prepare and improve QA procedures; Assist with client audits and regulatory inspections; Archive and document control
Seniority
Mid-level, hands-on IC
