Demo

Document Control Specialist

ICONMA
Kennebunk, ME Full Time
POSTED ON 2/5/2025
AVAILABLE BEFORE 5/4/2025

Our Client, a Business Manufacturing And Supply company, is looking for a Document Control Specialist for their Kennebunk, ME location.

Responsibilities :

  • Responsible for administration of quality management system documents and records required for Client Life Sciences processes.
  • Responsible for initiation of document changes, distributions, notifications and fulfilling internal and external document distribution.
  • Generates, reviews, and maintains quality system documents including procedures, work instructions, job aids, certificate of conformances, etc. in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
  • Initiates Change Controls and Document Change Requests to update procedures and processes.
  • Works within departments and with various departments to update processes and procedures.
  • Assists in managing the document review and retention processes.
  • Supports or leads continuous improvement initiatives for document control related processes.
  • Supports other Quality Assurance functions as needed (internal audit, CAPAs, etc.)
  • Other duties as required

Requirements :

  • 2 years related experience required.
  • Proficiency in Microsoft Office and Excel
  • Ability to follow written procedures
  • Detail oriented
  • Ability to work autonomously
  • Associate or bachelor's degree in life sciences, engineering, or a related field preferred.
  • Prior experience in a manufacturing environment is preferred.
  • Previous experience using ETQ or other Document Management software preferred
  • Proficiency in Microsoft office
  • Experience in ISO 9001 or other Quality System standards
  • ISO 13485 and 21 CFR 820 Quality Management Systems knowledge highly preferred
  • Must be detail oriented and accurate in execution of work
  • Able to work well both independently and in a group setting
  • Why Should You Apply?

  • Health Benefits
  • Referral Program
  • Excellent growth and advancement opportunities
  • As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.

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