Document Control Specialist

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