Validation Software Facilitator

Support IT systems by providing software quality assurance services for regulated and non-regulated computerized systems. Assure systems adhere to quality standards and applicable regulations throughout the computerized System Life Cycle (SLC).

RESPONSIBILITIES:
Specific tasks include but not limited to:

- Validation Master Planning for IT Systems
- SLC Review board sponsorship
- SLC deliverable review and approval
- Requirements/traceability verification
- Certification Summaries
- IT System Production Incident Reports
- IT System Exception Report support
- Policy/procedural changes and approvals, as appropriate
- Audit/inspection support
- Periodic reviews
- IT Supplier/Service Provider Evaluation review and approval
- GPO Library Administration
- Corporate/Divisional Compliance Plan implementation and support.
- Responsible for all software quality assurance activities such as evaluation of software life cycle deliverables for compliance with Operating Procedures, FDA requirements and the CFR including 21 CFR Part 11.
- Lead or participate in various reviews, risk analyses and other software quality assurance activities.

SKILLS:

Minimum Bachelor's degree, Have a background in software engineering, software life cycle activities, or software validation and be familiar with the work products that result from SLC key activities.

- Must be hands-on and professional
- Knowledge or experience in requirements gathering, analysis techniques, software verification/validation techniques, configuration management techniques or documentation standards.
- Should be familiar with IEEE, SEI, ISO and have experience in a regulated environment.
- Analytical skills are important, as is the ability to manage tasks. Must be able to manage multiple tasks and resources.
- Good with verbal and written communication skills.