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Document Control Specialist

LKA & Associates LLC

  • Warsaw, IN
  • 1 day ago
  • $20–$25

Highlights

Job Title: Document Control Specialist Work Location: Warsaw, IN 46580 Duration: 12 Months Work Type: Onsite Duties: Responsible for leading document control and records management processes and for ensuring records are processed retained and updated appropriately. Serves as the right hand of the department supervisor, helping to process changes and organize daily department priorities, by developing and maintaining trackers and meeting with individual team members.

Numbers & Facts

LocationWarsaw, IN
Salary$20–$25

Description

Job Title: Document Control Specialist
Work Location:Warsaw, IN 46580
Duration: 12 Months
Work Type: Onsite
Duties:
  • Responsible for leading document control and records management processes and for ensuring records are processed retained and updated appropriately.
  • Responsible for giving direction to team members within the records management and document control groups and leading projects.
  • Serves as the right hand of the department supervisor, helping to process changes and organize daily department priorities, by developing and maintaining trackers and meeting with individual team members
  • Answers questions and gives guidance to records management and document control coordinators
  • Trains peers on various processes
  • Authors and develops new documents and processes
  • Manages change control processes and meetings with TMs to ensure timely processing of change requests.
  • Identifies and initiates projects to improve department processes with little to no oversight
Education:
  • BS/BA in engineering, business, life sciences or a similar discipline required.
  • Minimum of 3 - 5 years of experience in a Quality Control, Quality Assurance or Compliance roles, preferably in a document control or function in the medical device or life sciences industry.
  • Working Knowledge of 21CFR Parts 11 and 820, including ISO 13485 QMS.
  • Experience with electronic Document Management (eDM) systems is preferred.
  • Prior experience of participating in compliance audits or inspections is preferred

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