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.

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