JOB DESCRIPTION:
As a member of the global metrics production team of QuintilesIMS Quality Assurance, primary job duties include entry and QC of data into the TrackWise database in support of the auditing program and processes across all Global QA business units. Also frequent use of clinical systems in support of the metrics team to look up trial related information will be included as part of this role.  A majority of time is spent divided between metrics production/data and record qc and querying/and entry of data into systems.

RESPONSIBILITIES
In support of QA Metrics team you will be a part of a team responsible for:
•        Audit entry into the TrackWise system from audit plans or audit notification documentation received through the HP ServiceNow ticketing system, within the agreed timelines
•        QC of Audit information or follow-up as required, related to missing Information for the planned audits identified and entered into the system.  This may include confirmation of audits performed, follow-up on report issuance, follow-up until Corrective And Preventive Actions agreed or overdue CAPAs.
•        Providing support to staff by answering queries and/or providing data
•        Producing documentation from data sources, including status reports of overdue information, tables and graphs as required
•        Maintaining the QA filing systems for audit lifecycle tracking, including electronic filing of documentation and correspondence
•        Assisting in documentation required for customer audits

A good working knowledge of excel is required as much of the work we will train you on involves filtering, pivot tables and charting.  MSOffice knowledge is required.  TrackWise knowledge is a plus!  We adhere to a tight production schedule the first two weeks of each month, so if you enjoy data and systems this is the place for your entry into the GCP world.  Welcome anyone with batch record review skills.

Contact:
Diane Mikolay
Director, QA
4820 Emperor Blvd.
Durham, NC 27701

Office: +1 919/998-7667
Mobile: +1 919/802-1759

diane.mikolay@quintilesims.com
www.quintilesims.com