Document Control Associate

Polymer Technology Systems, Inc • Whitestown, IN

7d • Onsite

About The Position

The Document Control Associate is responsible for maintaining the integrity of the Quality Management System (QMS) in a regulated medical device manufacturing environment. This role ensures Quality System documentation is accurate, current, properly approved, and distributed in compliance with applicable regulations. The ideal candidate is detail-oriented, thrives in process-driven work, and is committed to long-term growth within a compliance-focused team.

Requirements

• Exceptional attention to detail with the ability to identify errors, inconsistencies, and non-conformances in documentation.
• Demonstrated ability to follow written procedures precisely with minimal deviation.
• Ability to adapt to change and work flexibly in an active, sometimes high-traffic environment.
• Compliance to applicable quality system and regulatory requirements.
• Adopts a “quality in everything we do” approach to all aspects of the execution of responsibilities of this position.
• Vigilance to remain alert to any potential compliance situations, and must report such observations to managers and the Head of Quality.

Nice To Haves

• 1–3 years of experience in document control, records management, quality administration, or a related administrative role in a regulated industry is preferred.
• Prior experience in medical device, pharmaceutical, or other FDA-regulated manufacturing environment is a strong plus.
• Experience with an electronic Quality Management System (eQMS) such as QT9, MasterControl, Veeva, or equivalent is a plus.
• Equivalent combination of education and experience will be considered.

Responsibilities

• Distribute documents for revision to appropriate users and remove obsolete documents within the QT9 eQMS or shared server.
• Maintain “Master” and electronic files of Quality System documentation in QT9 or on shared server.
• Ensure change control compliance by reviewing completeness, accuracy, and proper document approval of all quality system records.
• Confer with document originators and approvers collaboratively to prepare controlled documents conforming to company format and standards.
• Help create and revise quality system documents as required.
• Notify all affected departments of document changes and effective dates.
• Perform duties as defined in document control policies and procedures.
• Perform scanning and filing of documentation as required.
• Communicate clearly with all personnel to ensure document routings and distributions are handled in a timely fashion.
• Support rework, deviations, and nonconformance processes by assigning numbers, completing QAD tasks, and reviewing documentation for correctness.
• Maintain records regarding the status of all document and change control processes.
• Send out training in QT9 eQMS for new and revised documents.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree