Altasciences seeks a QA Auditor to conduct systematic audits of clinical and laboratory trial activities, documents, and processes. The role ensures regulatory compliance with protocols, SOPs, and GxP requirements, reporting findings to study teams and management while identifying improvement opportunities.
Responsibilities
- Audit laboratory and clinical study phases, reports, and related documentation for regulatory compliance
- Conduct in-life audits, process audits, vendor qualifications, and equipment validation audits
- Write and issue inspection reports; communicate findings clearly to internal clients and evaluate responses
- Identify process improvement opportunities based on audit observations and participate in improvement initiatives
- Maintain QA records and study files; notify management of quality and compliance trends
Requirements
- Bachelor's degree in Chemistry, Biochemistry, Biology, or equivalent field
- Equivalent combination of education and pharmaceutical industry experience
- Legal work authorization in the United States; no sponsorship available
- Knowledge of GCP, GLP, and GCLP regulatory requirements
- Ability to conduct audits across multiple disciplines and study phases
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This position is listed as full time and onsite.