Document Control Specialist

Fremont, (none selected)

Posted: 07/01/2019 Employment Type: Contract Industry: Medical Device Job Number: JOS000008708

Job Description

SUMMARY: With little supervision, compiles and maintains document control records and related files to release drawings and engineering documents to manufacturing, product development and other operating departments by performing the duties listed below. In addition, creates training profiles for employees, procedures and controls the performance of the programs. Ensuring it conforms to the established company standards. 

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. 

- Reviews the classification/significance of a document. Changes and assigns the appropriate approvers. 

- Manages all aspects of change order processing for Maine upload. 

- Prepares document process metrics. 

- Creates training profiles and updates training history for each Maine employee. 

- Maintains validation files/records for site. 

- Examines documents such as drawings, change orders, and specifications to verify completeness and accuracy of data. 

- Confers with document originators or engineering personnel in Maine to resolve discrepancies and compile required changes to documents. 

- Posts changes to CPro, releases documents and notifies affected departments. 

- Maintains related files. Prepares requests for reproduction of documents. 

- Operates reproduction equipment. Prepares reports and memorandums. 

- Enters engineering data into document control system(s). 

- Follows all pertinent standard operating procedures. 

- Performs other duties as may be assigned 

- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance 

- Works on projects of moderate complexity and requiring some supervision. Compiling and analyzing data and creating reports 

EDUCATION and/or EXPERIENCE:  

High school diploma or general education degree (GED) plus 5+ years of related experience and full knowledge of technology and/or computer skills. 

OTHER SKILLS and ABILITIES:  

Ability to use PCs, Macintosh, and associated software, including databases. Ability to use on-line document retrieval systems. General knowledge of GMPs and internal document control systems. Ability to work with associates at all levels of the organization. Thorough knowledge of internal standards of operations. Good written and oral English communication skills. 

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