As a member of the IT Quality & Regulatory Compliance team, the Lead IT Analyst Regulatory Compliance helps to define, plan, and perform duties that support major system development life cycle activities, including validation review and change control approval of IT systems.
PRINCIPAL DUTIES & RESPONSIBILITIES:
•Approve system life cycle deliverables 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 & Regulatory Compliance on cross-functional teams in support of SDLC activities.
•Consult on the authoring and conformance of validation-related deliverables and activities in regard 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 (deviations, incidents, etc.)
•Assist in the development of IT Controls
•Advise technical personnel and management on regulatory compliance and interpretation and recommend appropriate corrective actions where needed.
JOB DEMANDS:
This job requires the Quality Assurance and Validation Specialist to attend department and user meetings, system assessment meetings, trainings, and other essential tasks. The Quality Assurance and Validation Specialist must maintain a professional manner in representing the company and in working with its agents and associates. The Quality Assurance and Validation Specialist 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 timeline driven.
JOB IMPACT:
The Quality Assurance and Validation Specialist’s role is essential in maintaining systems that are compliant with both regulatory (e.g., FDA) and corporate requirements and good business practices.