Temporary - Senior Document Control Coordinato

Temporary Senior Document Control Coordinator/Archivist
Position Objective
To support document control and validation review activities in a regulated environment.
Essential Functions
Document Control
- Operate computer programs or equipment to compile, type, revise, combine, edit, print, file, route and store documents.

- Process change requests in accordance with established procedures including review, routing and issuance of documents

- Ensure document control process is maintained appropriately.

- Maintain filing and archiving of all master documents, batch records and laboratory notebooks.

- Store completed documents in the appropriate data files and storage medium

- Support customer and regulatory and audits.


- Validation
-
Support implementation and testing of equipment / EDMS system by reviewing and approving qualification documents.

-
Review and approval of life cycle documentation (URS, FRS, DDS, Validation Risk Assessments for equipment.

Nature and Scope:

This position interfaces at all levels of the organization. At times, the assignments can be demanding with specific timelines.

Education:
Minimum Associate degree
BA / BS preferred.


Experience:

- A minimum of 3 years of experience in document control / validation / and quality assurance is desired.

- Required computer skills including Word 2007, Access.

- Validation experience required


Contacts:
Has contact with all levels of company employees


Working Conditions:

- Typically Office setting.