Job Summary
A scientific diagnostics company is seeking a Remote Senior Global QA Computer Systems Compliance Specialist.
Candidates will be responsible for the following:
- Reviewing and approving regulatory required documentation and ensuring compliance
- Supporting global project teams and sites as needed
- Demonstrating flexibility to support global projects for sites within various time zones
Qualifications for this position include:
- Up to 25% domestic and/or international travel may be required
- Bachelor’s Degree or higher in Science, Engineering or QA/Regulatory related course of study
- Minimum of 7 years experience in a regulated industry with pharma experience in QA, QC or Regulatory Affairs
- Experience with GxP computer system regulations and GAMP 5
- Ability to evaluate and resolve complex technical problems
- Strong knowledge of change management processes