Josh Neiman
Computer Systems Validation Manager
- Alkermes
Quality/IT professional with more than twelve years of experience supporting electronic systems in the biopharmaceutical industry. Extensive knowledge of GMPs, Part 11 compliance, and other industry regulations. Experience with computer systems validation, continuous improvement of business processes and system support to ensure compliance with industry regulations.
Specialties: Strong analytical skills and proven experience in process improvement. Technical skills including query and report development using Access, Crystal Reports, Business Objects, SQL, and VBA. Experience supporting training, documentation, discrepancy management, and change control quality systems.