Hawkins Point Partners IT Quality/Computer Systems Validation Analyst in Cambridge, Massachusetts
Hawkins Point Partners is looking for IT Quality/CSV Analyst to join our Quality & Compliance team.
Person must be a mid- senior level able to independently drive tactical tasks to completion such as developing SOP’s, working with business teams to review vendor documents and complete CSV deliverables. Flexible and able to scale approaches based on phase, risk and business needs. Analytical risk based decision maker able to solution and document decisions using technical writing skills.
Responsibilities: Develop IT SOP’s, Forms for IT compliance, CSV, data management (transfer and exchange of data in clinical studies), data integrity, It security, CSV
Awareness and in depth knowledge of CSV (GxP), especially clinical.
Ability to work with business to complete new and retrospective System impact assessments.
Update and manage system inventory
Support CSV projects as back up when needed
Support inspection preparation
Knowledge of SOX, It security and infrastructure would be advantageous
At Hawkins Point Partners we believe in creating great experiences for our colleagues. We offer competitive compensation along with comprehensive benefit options to meet the diverse needs of our colleagues in their personal and professional lives.