QA Systems Associate Document Control

POSITION SUMMARY:

Under the direction of the QA Document Control Supervisor, the QA Systems Associate – Document Control, will be responsible for searching, reviewing, comparing and verifying data using Excel spreadsheet, MasterControl, and SAP OpenText.

This individual will work closely with IT Validation team for the purpose of data review and for

migration process. This individual will have a working knowledge of document management life cycle.

Responsibilities:

Maintain quality system controls to ensure state of compliance.

Take appropriate steps to reduce wastages and losses in the process.

Under guidance of the QA Document Control Supervisor the QA Systems Associate - Document Control will:

Be a liaison between QADC and IT Validation Team for the purpose of reviewing, correcting, coordinating, and communicating issues relating to the DMS validation project:

Review Excel data against set criteria.

Search and edit in MasterControl

Perform document review against set criteria/protocol.

Execute activities within the Document Management Systems in a compliant manner.

Education:

Associate degree in scientific discipline or closely related technical field of study preferred.

High School Diploma required.

Experience:

• 2-5 years of Pharmaceutical and FDA/GMP industry experience is preferred.

• Previous Quality experience is preferred.

• Any IT quality certifications a plus