QA Auditor 2

Plan, schedule, conduct, report, and close audit activities assessing compliance with regulations, customer requirements, SOPs, and project guidelines across multiple countries.

Manage Quality Issues including review and approval of investigations, Root Cause Analysis, CAPA and Effectiveness Checks, and oversee closure tracking for quality events arising from audits and inspections.

Host customer audits, regulatory inspections, and ensure proper conduct of audits; maintain and support electronic quality management system (eQMS) and audit lifecycle management.

Bachelor's Degree preferred.

4+ years experience in pharmaceutical, technical, or related area with GXP and/or Quality Assurance experience (equivalent combinations accepted).

Knowledge of GXP regulations and quality assurance auditing techniques required.

Experience with word-processing, spreadsheet, and database applications; no explicit mention of notice period or location requirements.

Experienced in conducting audits and managing quality compliance in regulated environments with international scope.

Capable of providing regulatory interpretation and consultation to project teams, customers, and management.

Skilled in managing multiple QA initiatives/projects, quality events in eQMS, and supporting quality process improvements with effective communication and organization.