Document Control Specialist

Our client, a Medical Devices / Healthcare company, is looking for a Document Control Specialist for their Warsaw, IN location.

Responsibilities:

• 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

Requirements:

• Action oriented, drives for and achieves results.
• Must be proficient in MS Office and Sharepoint.
• Strong bias for coaching and mentoring others. This includes ability to effectively train team members within a class-room or workshop setting.
• Proven strong writing and editing skills.
• Proven excellent attention to detail and proofreading skills.
• Strong organizational skills and the ability to multi-task.
• Strong and effective communicator (written and verbal).
• Motivated and proven ability to work in a team-oriented, global environment, including interacting effectively with all levels and outside contacts.
• Excellent problem identification and solving skills.
• Sound decision making skills, solid under pressure.
• Effective process development and process management skills.
• 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

Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities