Quality Assurance - IT

A Quality Assurance Specialist in Information Technology leads compliance initiatives in support of company policies and Regulatory requirements to support product and internal IT controls related to 21 CFR Part 820 & Part 11, Annex 11, and other health care industry standards/best practices.

IT QA also assists our IT unit to integrate best practice concepts into our processes to increase efficiency and meet compliance requirements and assure our customers receive only the highest quality services.

Day to day responsibilities include:

• Support Application teams to facilitate the SDLC process for new Applications & Systems.
• Perform Risk Impact Analysis for Infrastructure and Application installations and upgrades.
• Provide guidance on Quality System Regulations to define applicable requirements.
• Assist Project Managers to define applicable project deliverables and create project plans and reports.
• Assist Project Managers to define appropriate levels of governance for individual projects.
• Collaborate with teams to develop testing strategies.
• Review project deliverables to assure quality system standards and internal procedural requirements are met.
• Review and approve test instructions and records in support of validation activities.
• Work with IT personnel to improve efficiency of the SDLC/ALM processes and compliance to QSR and ISO standards.
• Apply standard CAPA techniques (containment, correction, investigation, corrective action, etc.) to clear issues impeding project completion.
• Write, update and/or review IT procedures and work instructions.
• Keeps abreast of trends and applications.
• Leads smaller projects.
• Performs work on several functions/applications.