Document Control Specialist

Job Summary

We are seeking an experienced Senior Document Control & Records Management Specialist to lead document control and records management activities. This role is responsible for ensuring documents and records are accurately processed, maintained, retained, and updated. The individual will provide guidance to team members, manage change control activities, support daily department operations, and drive process improvements.

Key Responsibilities

• Support the department supervisor in managing daily priorities, processing changes, maintaining trackers, and coordinating with team members.

• Provide guidance and support to Records Management and Document Control Coordinators.

• Train and mentor team members on department processes and procedures.

• Author, develop, review, and maintain documents and process documentation.

• Manage change control processes and coordinate meetings with team members to ensure timely processing of change requests.

• Identify and lead process improvement projects independently.

• Ensure proper processing, retention, maintenance, and updating of records.

Required Skills

• Proficiency in MS Office and SharePoint.

• Strong coaching, mentoring, and training skills.

• Excellent writing, editing, and proofreading abilities.

• Strong attention to detail and organizational skills.

• Ability to manage multiple priorities and work under pressure.

• Excellent written and verbal communication skills.

• Strong problem-solving and decision-making abilities.

• Experience in process development and process management.

• Ability to work effectively in a global, team-oriented environment.

Education & Experience

• Bachelor's degree in Engineering, Business, Life Sciences, or a related discipline.

• 3–5 years of experience in Quality Control, Quality Assurance, or Compliance.

• Experience in Document Control or Records Management, preferably within the Medical Device or Life Sciences industry.

• Working knowledge of 21 CFR Part 11, 21 CFR Part 820, and ISO 13485 QMS.

• Experience with electronic Document Management Systems (eDMS) preferred.

• Prior participation in compliance audits or inspections preferred.