Senior Document Controller

Senior Document Controller
Company:

Externetworks Inc


Senior Document Controller

Details of the offer

Job Summary
Under minimal supervision, maintains Device Master Record and Device History Records as part of the quality system, and maintains department databases within a cGMP environment. Medical Device and/or Pharmaceutical industry experience a plus.
Principal Duties and Responsibilities
Creation of Device Master Records such as routers, master cross references, and bill of materials within the ERP system.
Maintain Device Master Records and Device History Records as well as other quality system documents such as training records, monitoring records, authorized signature lists, etc.
Assist with new part number assignment process by creating new part numbers within ERP system for design teams and Marketing department.
Handle distribution of all change orders (engineering, specification, and labeling) to appropriate departments.
Assist with the maintenance of the company intranet, Livelink/SAP web based software to ensure the most current document revisions are available at all points of use.
Assist with processing Instructions for Use and all labeling intended for domestic and international distribution. This includes approval of product labeling using the label producer software.
Maintenance of various databases to ensure compliance to regulations such as indices used for procedures, drawings etc.
Assist with preparing and organizing documents for offsite storage archival and/or archival onto CD. Maintain storage logs.
Process and distribute various document requests to departments as needed.
Complete various projects as assigned by the supervisor in addition to general filing and copying.

Expected Areas of Competence:
Ability to objectively deal with individuals using appropriate tact and diplomacy to establish and maintain a congenial relationship.
Good verbal and written communication skills.
Good word processing and database skills.
Outstanding organizational skills and high attention to detail.
Knowledge of current Food and Drug Administration (FDA) laws, regulations and practices a plus.

Education/ Experience Requirements
Some college education or equivalent plus one to two years previous regulatory/quality or related experience and six months on-the-job training, or an equivalent combination of education and experience. Experience in the Medical Device and/or Pharmaceutical industry a significant plus.

Job Type: Contract
Experience:
Medical Device or Pharma Industry: 2 years (Required)
Regulatory Affairs: 3 years (Required)

Contract Renewal:
Likely


Source: Jobsxl


Area:

  • Other Jobs / Other Jobs - Crafts

Requirements

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