Lead Batch Reviewer at GBA in Baltimore, Maryland

Job Description:

LOCALCANDIDATES ONLY

Execute the initiation and/or evaluate deviation(s), interview personnel, analyze root cause, assess impact, identify corrective / preventive actions, present to management and close investigations in the Quality Management System (QMS).. The Reviewers in this role will be responsible for executing root cause investigations, owning/authoring deviations, driving continuous improvement efforts. They will also manage both minor and major investigations as relates to Batch Record reviews. Work on a team under a Senior Manager. Cell/Gene Therapy experience preferred. The Lead Reviewer will also be responsible for reporting to the client management on a weekly basis on review details, project progress and project metrics, as well as providing coaching and training for the staff reviewers.