CONTRACT: 18 months
PAY RATE: $50 - 55 hrly
Responsibilities include, but are not limited to:
* Coordinates with pertinent internal functional groups as needed to facilitate timely processing of new documents, document changes and change controls.
* Reviews internal documents prior to issuance to confirm complies with standards and works with document owners / change authors to resolve deficiencies.
* Supports maintenance of QMS record storage, including preparation and documentation of records for transfer to off-sire location or disposal.
* Administrates the review of internal documents according to planned arrangements and external documents upon notification of update release.
* Provides copies of change controls, reports and other applicable documents
* Provides support to the continual improvement of document control and record management.
EDUCATIONAL REQUIREMENTS (degree, license, certification):
* Minimum of two years of college or equivalent work experience
YEARS OF EXPERIENCE:
* 3 or more years in medical device or pharmaceutical document and change control management.
OTHER SKILLS AND ABILITIES:
* Strong computer skills. Fluent with Microsoft Office business software, particularly Microsoft Word, Excel and PowerPoint.
* Experience with eQMS software for document and record management. Familiarity with document control management using MasterControl a plus.
* Knowledge of GMP, ISO, QSR and other applicable international standards, regulations, directives and guidance.
* Familiarity with CAD software and reading technical drawings.
* Experience with document indexing structures, scanning and high-volume printing.
* Proven ability to communicate effectively, orally and written.