Summary of Tasks:
Participate in Full CSV SDLC documentation support within a FDA regulated environment with an emphasis on enterprise-scale IT systems including but not limited to:
- Requirements elicitation and engineering
- Performing data integrity/data quality assessments
- Authoring and reviewing user requirements / functional requirements specifications, design specifications, computer validation plans, test protocols, data integrity assessments and part 11/annex 11 assessments.
- Tracking and maintaining document records and metrics in the SharePoint, DocCompliance and ValGenesis systems.