Overview
Seeking an experienced R&D Quality Assurance Specialist to support GCP/GVP audit activities within a pharmaceutical or biotech environment. This role will focus on audit preparation, documentation, reporting, records management, and quality tracking, with a strong emphasis on Veeva Quality Vault.
Key Responsibilities
- Support the planning, preparation, execution, closure, and reporting of GCP/GVP audit activities.
- Maintain audit-related records and documentation throughout the audit lifecycle.
- Compile relevant data and documentation in preparation for audits.
- Input and maintain audit reports within the Veeva Quality Vault Audit Module.
- Support audit data migration and quality metrics tracking/trending.
- Coordinate follow-up activities with internal and cross-functional stakeholders.
- Assist with developing standardized templates and continuous improvement initiatives.
- Ensure audit documentation and records are accurate, organized, and up to date.
Required Skills
- Hands-on, daily experience with Veeva Quality Vault; Audit Module experience strongly preferred.
- Working knowledge of GCP and/or GVP processes and clinical quality auditing.
- Experience supporting audit preparation, documentation, and records management.
- Strong organizational skills and exceptional attention to detail.
- Ability to gather, organize, and communicate information across cross-functional teams.
- Strong written and verbal communication skills.
- Proficiency with Microsoft Office.
Education & Experience
- Bachelor’s degree in Life Sciences, STEM, or related field + 4+ years of relevant experience in biotech, pharmaceutical, clinical research, or related industry, OR
- No formal degree + 6+ years of relevant industry experience.