Senior QA Associate I
Core
Conducting study-specific inspections, internal audits, and providing quality consultation to ensure compliance with protocols, policies, and GxP regulations in life sciences research.
Role type
Senior IC Quality Assurance Auditor
Builds
Compliance assurance for research studies and internal processes
Domain
Life Sciences / Regulatory Affairs / Quality Assurance
Deliverable
client delivery
Required skills
GxP regulatory standards knowledge, audit planning and execution, risk evaluation of compliance deficiencies, data and protocol review, regulatory agency inspection support, training on GLP regulations
Preferred skills
Accreditation by a professional body (e.g., ASQ CQM or CQA)
Technologies
None stated
Responsibilities
Plan, organize, and lead study-specific inspections and internal system/process-based audits; Review raw data, protocols, and research reports to assure quality and integrity; Provide guidance and training on GLP regulations to auditors and personnel; Assist the Inspection Management group on regulatory agency inspections; Prepare and present project progress reports to management
Seniority
Senior, hands-on IC with supervisory oversight