Quality Systems Specialist — Docs, Audits & Compliance

Replimune; Framingham (MA); On-site; USD 101,500 - 131,500; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k match

Flexible time off

Year-end shutdown

Job summary

Replimune is seeking a Quality Systems support professional to strengthen cGMP compliance at the Framingham site. The role focuses on document control, archival tasks, and ensuring audit-ready records across multiple platforms.

The candidate will manage MasterControl and related systems, assist with onboarding and internal audits, and support day-to-day operations for multiple sites within a regulated manufacturing environment.

Qualifications

• Bachelor's degree in a regulated manufacturing environment or equivalent.
• Minimum 4 years of relevant experience in quality/document control.

Responsibilities

• Archive, organize, and maintain controlled documents.
• Coordinate shipment, tracking, storage, and retrieval for archival facilities.
• Prepare and package documents for off-site storage per GDP and retention procedures.
• Create and maintain batch records, lab notebooks, and logbooks.
• Manage document requests via Jira and provide timely support.

Skills

Document control

Cross-functional collaboration

Time management

Communication skills

Attention to detail

Problem solving

MS Office proficiency

Education

Bachelor's degree in regulated environment

Tools

MasterControl

Veeva

Jira

Excel

Word

PowerPoint

Access

Job description

Replimune is seeking a Quality Systems support professional to strengthen cGMP compliance at the Framingham site. The role focuses on document control, archival tasks, and ensuring audit-ready records across multiple platforms.

The candidate will manage MasterControl and related systems, assist with onboarding and internal audits, and support day-to-day operations for multiple sites within a regulated manufacturing environment.