Document Control Associate in Vista at Vaco

Date Posted: 3/11/2020

Job Snapshot

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  • Location:
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  • Experience:
    At least 1 year(s)
  • Date Posted:
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Job Description

Supports the document control systems by reviewing all documents submitted for approval routing, route and track documents for approval, release documents and distribute copies. Responsible to ensure current documentation revisions are available while identifying and archiving/removing obsolete documents. Entry level position within job family requiring 0-2 years of related experience in an FDA regulated industry, completes routine tasks, and receives detailed instructions on all work under close supervision. Experience with document control software and regulatory requirements such as 21 CRF Part 11/820 and ISO 13485 a plus.

Core Job Responsibilities:

Responsible for the administration of document management systems to maintain Quality System documents and records. Ensures that good document practices are met and adhered to. May provide internal systems support to regulatory departments. Maintains documentation manuals to ensure they are accurate and up-to-date and available to appropriate personnel. Provide administration of document management system. This position will establish and maintain the process and procedures for management and maintenance of the systems workflows/configuration. Interface and build strong partnerships with IT, Engineering, Manufacturing, R&D and other parts of Quality organization.

Essential Functions:

  • Manage the configuration of the QMS in collaboration with the system owner in compliance with internal procedures and policies as well as regulatory requirements.
  • Manage the workflows for routing, review, approval, distribution and archival of new and revised controlled documents. Manage established user groups and periodically review access/security and audit trails.
  • Provide system specific support and troubleshooting for IT trouble tickets. Escalate issues as needed to the next support level with the system supplier.
  • System administration point of contact for IT and the system supplier.
  • Develop and maintain system administration procedures, training and guidance on document and records management roles, and processes.
  • Support system upgrades and changes with technical expertise and hands on implementation and test activities as needed.
  • Establish best practices.
  • Support regulatory audits as needed.
  • Work on multiple assignments in collaboration with various department system owners.
  • Serve as backup for document control (review and routing of documents).
Knowledge, Skills and Abilities (KSA):

The document control team must possess the following skills and demonstrate increasing proficiency in each area throughout their career development.

  • Excellent analytical skills Strong knowledge of GDP, SOPs and quality systems.
  • Excellent computer system administration and configuration skills.
  • High attention to details.
  • Strong knowledge of ISO 13485
  • Computer System Validation. Multitasking and prioritization skills.
  • Advanced Skills with MS Office applications Word, Excel, Access, as well as Adobe Acrobat.
  • Strong written and verbal communication skills.
  • Ability to communicate and work independently with scientific/technical personnel.