Quality Assurance Document Control Lead (GMP/ISO)

Young-Innovations; Illinois; On-site; USD 30,307 - 35,817; Full time

Benefits offered by this job

Health, dental, and vision coverage

Group RRSP

Parental leave

Paid time off

Short- and long-term disability

Job summary

Germiphene, a Young Innovations company, is seeking a detail-driven Quality Assurance Document Coordinator to maintain our controlled document system, manage QT9 document control, and track deliverables across investigations and change controls in a regulated dental pharmaceutical manufacturing environment.

You will administer the QT9 training program, support audits, and generate metrics for management reviews, reporting to the Quality Assurance Supervisor.

Qualifications

• 3+ years in a regulated GMP/ISO 13485 manufacturing environment.
• Experience with electronic QMS platforms (QT9 preferred).
• Advanced proficiency in Microsoft Office.
• Strong written and oral communication.
• Excellent organizational skills with attention to timelines.

Responsibilities

• Document Control: maintain Master Document List, archives, and approvals.
• Deliverable & Timeline Tracking: monitor investigations and change controls.
• Training Administration: manage QT9 training program and roll-out of new docs.
• Audit Readiness & Reporting: assist audits and compile QMS metrics.
• Coordinate across Quality team to ensure timely closure of tasks.

Skills

QT9

Microsoft Office

Document control

Tracking & scheduling

Audits preparation

Regulatory compliance

Communication skills

Project management

Education

High School Diploma

Tools

QT9

MasterControl

TrackWise

ETQ

Job description

Germiphene, a Young Innovations company, is seeking a detail-driven Quality Assurance Document Coordinator to maintain our controlled document system, manage QT9 document control, and track deliverables across investigations and change controls in a regulated dental pharmaceutical manufacturing environment.

You will administer the QT9 training program, support audits, and generate metrics for management reviews, reporting to the Quality Assurance Supervisor.