This job requires the IT Quality Analyst to attend department and user meetings, system assessment meetings, trainings, and other essential tasks. The IT Quality Analyst must maintain a professional manner in representing the company and in working with its agents and associates. The individual should demonstrate initiative and self-direction while also knowing when to seek assistance. This person must also be able to routinely schedule and complete multiple tasks and be
- Approve system life cycle deliverables (SDLC} and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities.
- Represent IT Quality on cross-functional teams with IT R & D in support of SDLC activities.
- Consult on the authoring and conformance of validation-related deliverables and activities in regards to corporate SOPs and current regulations.
- Provide guidance, training and support to IT personnel in their validation efforts, to ensure compliance.
- Provide quality assurance oversight for system related issues (Test incidents, issues, etc.)
- Advise technical personnel and project teams on regulatory compliance and interpretation and recommend appropriate corrective actions where needed.
- Bachelor’s/Master’s Degree
- 7+ years IT Quality / Validation experience in computerized system validation within a regulated environment preferably R & D application.
- Thorough knowledge of GxP and ERES (21CFR Part 11 and Annex 11) regulations and guidelines
- Detailed knowledge of the IT system development life cycle and software quality assurance in a regulated environment
- Thorough knowledge of IT Controls methodologies, including GAMPS and ITIL
- Experience with risk analysis and risk management practices and tools
- Excellent communication skills, both verbal and written
- Knowledge of general software, database concepts and Data Integrity
- Knowledge of infrastructure technology and platforms
- The ability to work both independently and with teams
- Interview process will be a phone and in-person.
Note: Qualified candidates will be contacted within 2 business days of application. If an applicant does not meet the above criteria, we will keep your resume on file for future opportunities and may contact you for further discussion