Senior Specialist, Digital & Data Quality
USD 104K-163K Senior-level Full Time
Tasks
- Approve acceptance criteria plans protocols reports
- Assess remediate legacy computerized systems
- Conduct periodic system reviews
- Develop maintain computerized systems validation training programs
- Ensure GMP computerized system quality
- Evaluate implement computerized systems for GxP
- Maintain validated status via change control and incident management
- Manage backup restore and disaster recovery plans
- Mentor junior team members
- Monitor system health and compliance metrics
- Promote GxP continuous improvement
- Provide quality oversight throughout computer system lifecycle
- Resolve regulatory non conformance
- Review SDLC documentation
- Review qualification validation documentation
- Support electronic data review and audit trail compliance
- Support regulatory inspections and audits
Perks/Benefits
- 401k retirement plan
- Comprehensive health benefits
- Hybrid work model
- Paid Holidays
- Paid sick days
- Vacation
Skills/Tech-stack
21 CFR Part 11 | 21 CFR Part 210 | 21 CFR Part 211 | 21 CFR part 820 | Business Continuity | CFR Part 11 | CFR Part 820 | Change Control | Computer system | Computer system validation | Deviation Management | Disaster Recovery | FDA 21 CFR | FDA 21 CFR Part 11 | FDA 21 CFR Part 210 | FDA 21 CFR Part 211 | FDA 21 CFR Part 820 | GAMP | GMP | GxP | Incident Management | Part 11 | Part 210 | Part 211 | Part 820 | Quality Auditing | Regulatory Compliance | System validation
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
Regions
Countries
States
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