Global Document Control & Quality Records Specialist

El Camino Health; United States; Remote; USD 12,000 - 18,000; Full time

Job summary

iRhythm Technologies, Inc. is seeking a Document Control Specialist to manage creation and revision of quality system documents and coordinate change orders within the global Document Control system.

The role supports audits and ensures timely, accurate documentation in GMP environments. The position requires strong communication, attention to detail, and proficiency with Microsoft Office; MasterControl experience is highly desirable.

Qualifications

• Strong communication and interpersonal skills for cross-functional collaboration.
• Attention to detail and timeliness in document control tasks.
• Proficiency with Microsoft Office Suite required.
• Experience with MasterControl is highly desirable.
• Understanding regulatory processes for document control and GMP environments.
• Bachelor’s degree or equivalent experience, with 2+ years in document management.
• Ability to work collaboratively and transparently across teams.
• Experience in FDA-regulated environments (cGMP/GDP/GCP) preferred.

Responsibilities

• Manage creation and revision of quality system documents.
• Maintain and coordinate the document change control process in the global system.
• Ensure timely completion and version control of documents.
• Support internal and external audits related to document control.
• Coordinate document requests and respond to audits as needed.
• Perform self-audits of satellite binders and ensure current revision is accessible.
• Maintain quality records per SOPs and support regulatory compliance.

Skills

Strong communication

Attention to detail

Microsoft Office

MasterControl experience

Cross-functional collaboration

Regulatory knowledge

cGMP/GDP/GCP familiarity

Education

Bachelor’s Degree or equivalent experience

Tools

MasterControl

Job description

iRhythm Technologies, Inc. is seeking a Document Control Specialist to manage creation and revision of quality system documents and coordinate change orders within the global Document Control system.

The role supports audits and ensures timely, accurate documentation in GMP environments. The position requires strong communication, attention to detail, and proficiency with Microsoft Office; MasterControl experience is highly desirable.