Document Control, Senior Specialist

Scorpion Therapeutics; United States; On-site; USD 110,000 - 150,000; Full time

Job summary

Scorpion Therapeutics in Bedford, MA is seeking a Senior Document Control Specialist to support quality systems within a biopharma environment, ensuring controlled documentation compliance.

You will administer global document control processes for GxP records, manage lifecycle, audits, and training, troubleshoot workflow issues, and assist with document migration from paper to electronic systems to ensure regulatory readiness and inspections.

Qualifications

• BS/BA with 8-10+ years in quality discipline.
• 5+ years in Document Control within pharma, medical device, or biotech sectors.
• Experience with eQMS platforms (TrackWise Digital, Veeva, MasterControl).
• Strong knowledge of GxP documentation, record retention, and regulatory audit support.
• Proficient in technical writing and MS Office.

Responsibilities

• Administer and oversee global document control processes for GxP records using electronic systems like TrackWise Digital.
• Support document lifecycle management, process improvements, audits, and training.
• Troubleshoot workflow issues.
• Assist with document migration and paper-to-electronic transitions.
• Ensure regulatory compliance and record retention.

Skills

Technical writing

MS Office

Attention to detail

Independent work

Effective communication

Education

BS/BA in a related field

Tools

TrackWise Digital

Veeva

MasterControl

Job description

Role: Senior Document Control Specialist supporting quality systems within a biopharma environment, ensuring controlled documentation compliance.

Responsibilities

• administer and oversee global document control processes for GxP records using electronic systems like TrackWise Digital
• support document lifecycle management, process improvements, audits, and training
• troubleshoot workflow issues
• assist with document migration and paper-to-electronic transitions
• ensure regulatory compliance and record retention

Requirements

• BS/BA with 8-10+ years in quality discipline
• 5+ years in Document Control within pharmaceutical, medical device, or biotech sectors
• experience with eQMS platforms (e.g., TrackWise Digital, Veeva, MasterControl)
• strong knowledge of GxP documentation, record retention, and regulatory audit support
• proficient in technical writing and MS Office

Preferred

• project management
• effective communication
• attention to detail
• ability to work independently

High-Value

• supporting GxP controlled documentation
• multi-site/global document control programs
• GMP compliance
• supporting inspections

Work Setup

on-site in Bedford, MA, 3 days/week; open to US-based applicants.