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Sr Doc Control Specialist

Sylmar, CA 91342

Posted: 06/03/2019 Employment Type: Contract to Direct Category: Computer Network Support Specialists Job Number: 81942

We are currently looking for an Sr. Document Control Specialist to join the team!

 

DUTIES/RESPONSIBILITIES
  • Responsible for the maintenance of the document control system, which includes the following activities
  • Processing Change Orders (CO)
  • Preparing new and/or maintaining existing documentation.
  • Blueprint review to assist Engineering with highlights of engineering changes submitted by customers.
  • Maintain the filing system (soft and hard) of active and inactive documents
  • Posting and retracting documents for posting location
  • Notifying both internal and external customers of implementation
  • Archiving documents for long-term storage and destruction of records that exceed documented retention period
  • Ensure documents of external origin are up-to-date
  • Maintain client standard and custom documents.
  • Assist in development of procedures to support the manufacturing, quality control, and other Quality Management System (QMS) processes.
  • Manage document project assignments as well as completion of assigned projects.
  • Examines, thoroughly tests and implements projects as submitted from compliance and implementation and identifies the correct application, 3rd party interface to be applied.
  • Responsible for technical documentation of procedures and practices.
  • Communicates and coordinates with IT/Integration department, Compliance and Implementation for any ERP system related queries
  • Generate and revise items and Bill of Materials (BOMs) in the ERP system
  • Assist with documentation support to other departments
  • Assist in scheduling training sessions for revised documentation and facilitate training as needed
  • Familiar with standard concepts, practices, and procedures within a particular field. Follows and adheres to established policies and procedures.
  • Support all customer, internal and supplier audits with respect to document control
  • Interfaces with customers to resolve all tiers/escalation customer service calls/inquiries/problems as it relates to client forms, the products and services.
  • Provides cross functional collaboration between internal and external teams.
  • Other duties as assigned

 

REQUIREMENTS
  • High school diploma/equivalent; some college preferred
  • Minimum of 5years administrative & document control experience
  • Knowledge of documentation control systems as it relates to FDA’ s QSR and ISO 13485
  • Good communication skills (e.g. verbal and written)
  • Customer Service experience and ability to multi-task
  • General knowledge of company products and services.
  • Ability to work in a fast-paced environment
  • Strong interpersonal skills
  • Performs and executes with general supervision, special assignments.
  • High attention to detail and quality
  • Working experience in the industry that is regulated (e.g. FDA) and is in compliance with ISO 9001/ISO 13485
  • Working experience with requirements for document control systems as it relates to FDA’ s QSR, ISO 9001 or ISO 13485
  • Good working knowledge of computer programs such as Adobe Professional, MS Word, Excel PowerPoint, Visio and Outlook
  • Knowledge of ERP software a plus.

Additional Notes:
  • High school diploma/equivalent; some college preferred
  • Minimum of 5years administrative & document control experience
  • Knowledge of documentation control systems as it relates to FDA’ s QSR and ISO 13485

 
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