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Document Control Specialist

Regenesis Biomedical, Inc.


Location:
Scottsdale, Arizona 85250
Date:
04/10/2018
2018-04-102018-05-10
Job Type:
Employee
Job Status:
Full Time
Shift:
1st Shift
Regenesis Biomedical, Inc.
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Job Details

POSITION SUMMARY

 

This position is responsible, under supervision, for creating, writing, editing and updating company-wide documentation via change orders. Assures document content is accurate, complete and satisfies internal and regulatory agency compliance expectations. Also responsible for coordinating Change Control Board activities, conducting periodic documentation reviews, and managing Quality Records and Employee Training.

 

ESSENTIAL DUTIES & RESPONSIBILITIES

 

  • Create, write, edit and update documents, forms, procedures, protocols, etc.
  • Create/process change orders, deviation orders and other change control documentation
  • Assure all Operations, Marketing, Manufacturing and other documents have accurate, complete content, references, etc. and fully satisfy internal and agency compliance expectations
  • Organize periodic documentation reviews
  • Coordinate/document Change Control Board activities
  • Manage Quality Records inventory; perform annual records audit; archive/retrieve records as necessary
  • Oversee Employee Training; verify training effectiveness is completed

Requirements

CORE COMPETENCIES / KNOWLEDGE & SKILL REQUIREMENTS

 

  • Must be PC literate with advanced MS Office skills (Word, Excel, PowerPoint, Visio, Outlook)
  • Proficient in editing PDF documents
  • Interpersonal and communications skills to work effectively with all levels of staff
  • Detail-oriented
  • Flexibility and creativity
  • Excellent organizational skills
  • Strong time management skills and multi-tasking abilities
  • Ability to manage projects, alone or as part of a team
  • GMP Document Control Regulations
  • Basic Mechanical/Assembly knowledge

EDUCATION, EXPERIENCE & TRAINING REQUIRED 

  • Minimum of 3 years general office experience

  • Minimum of 3 years of Document Control responsibility

  • Minimum high school diploma or G.E.D. equivalent

PREFERRED EXPERIENCE

 

  • AutoCAD, KeyCAD or CAD Lite experience
  • Knowledge of FDA Quality System Regulation and ISO 13485 requirements
  • Familiarity with CMS requirements
  • QA/QC experience
  • Scientific Literature searches
  • Associates or BA/BS in related field
Apply on the Company Site
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