Senior Software Quality Specialist
Prime Medicine, Cambridge, MA +1
What you need
- At minimum, a bachelor’s degree in a scientific, engineering, computer science, or other technical field, or equivalent relevant experience.
- At least 5 years of experience in a regulated life-sciences, medical-device, pharmaceutical, or other GxP environment, with hands-on responsibility for computerized systems, software assurance, or data integrity.
- Strong working knowledge of data-integrity principles, electronic records, computerized systems, software lifecycle controls, risk-based qualification or assurance, including 21 CFR Part 11, EU GMP Annex 11, GAMP 5, and computer software assurance guidance.
- Hands-on experience working with IT or system administration activities such as system configuration, access management, interfaces, data flows, troubleshooting, or implementation support.
- Experience supporting or leading deviations, CAPAs, change controls, investigations, or other controlled quality records involving software, computerized systems, or data.
- Experience drafting, executing, or reviewing qualification protocols, software assurance test scripts, vendor assessments, risk assessments, or other controlled quality records.