Senior Quality Assurance Validation Specialist (Oversight)

What You’ll Do:
- Generate, execute and/or review master and completed qualification/validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and acceptance criteria
- Analyze testing results and determine acceptability against pre-determined criteria
- Investigate and troubleshoot validation issues; recommend solutions and/or improvements
- Coordinate with functional departments to resolve validation issues
- Review, edit and approve deviation notifications, deviation investigations and corrective actions
- Coordinate with internal teams and outside contractors/vendors to complete validation tasks
- Develop tracking mechanisms for validation activity completion across projects and prepare status reports
- Present validation project/program status reports to senior management
- Ensure validation status is maintained for equipment and software use in commercial and clinical manufacturing
- Stay current with industry trends and regulatory requirement updates; communicate changes to teams
- May present at internal and external (regulatory) audits

Let’s Find Out If We’re a Fit:
- Requires B.S. in life sciences or related field; may substitute proven experience for education
- QA Validation Specialist: 4+ years of experience
- Sr. QA Validation Specialist: 6+ years of experience

Benefits:
- Student loan paydown program & tuition reimbursement
- Family care benefits
- Relocation assistance
- Inclusion, culture and well-being programs (including physical & mental health)

Application Instructions:
- Apply now