Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.
Knowledge in Organizational Excellence and Lean/Six Sigma is preferred.
Strong Project Management skills is preferred.
Knowledge of cost control, and development of guidelines, trainings, and maintenance programs is preferred.
Must have an understanding of verification and validation processes, including early software or computer systems defect detection and removal, inspection, and testing methods (e.g., types, levels, strategies, tools and documentation).
Have an understanding of Computer Systems Validation Life Cycle and regulatory requirements (GAMP 5 and FDA guidelines, among others).
Must have excellent communication skills and a strong track record of working cross-functionally.
Must have demonstrated ability to think strategically.
Teamwork oriented and self-starter.
0-3 years of experience.
Bachelor s Degree is required.