Document Control Specialist
: Job Details :


Document Control Specialist

Kaygen

Location: Vernon Hills,IL, USA

Date: 2024-09-24T06:39:06Z

Job Description:

Job Description:

Job Title: Coord 2, Quality Document Sys Mgmt

Location: 75 N. Fairway Dr, Vernon Hills, IL 60061 (Hybrid)

Duration: 07 months contract (Temp to Perm possibility)

Summary / Purpose of Position:

  • This role is responsible for the administration and coordination of the change control, documentation and training systems for BDI Surgery.

Job Description:

Essential Duties and Position Responsibilities:

  • Serve as the Electronic Document Management System (EDMS) and Learning Management System (LMS) administrator (e.g., maintain accurate users, assign passwords and privileges, update training requirements, etc.)
  • Ensure timely, accurate and efficient preparation and management of documents
  • Control the numbering, sorting, filing, storing and retrieval of both electronic and hard copy documents
  • Process changes via the EDMS systems
  • Provide database navigation and troubleshooting support for the EDMS, LMS system)
  • Assist managers to ensure required training is assigned and documented
  • Provide documentation and training compliance metrics as requested
  • Maintain central device master documentation
  • Maintain records in accordance with record retention policies.
  • Interface with internal and external auditors during review of the applicable quality management sub-systems (i.e., those pertaining to documentation, change control, and training)
  • Continuous improvement of the change control, documentation control, and training systems.
  • Successful completion of projects assigned by management to support business imperatives.
  • Other duties as assigned

Qualifications, Knowledge, and Skills Required:

  • Associate degree preferred, high school diploma or equivalent required.
  • Excellent verbal and written communication skills.
  • Strong collaboration across business functions.
  • Ability to aggressively drive results in multiple projects simultaneously.
  • Use of Microsoft Office software to generate formal procedures, control logs and databases.
  • Two years of relevant work experience required, preferably in a regulated medical device or pharmaceutical environment.
  • Understanding of blueprints, standard operating procedures, and overall documentation systems.
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