Senior Quality Systems Coordinator – Document Control

Replimune-2; 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

Paid holidays

Job summary

Replimune Group, Inc. is seeking a Quality Systems Document Control professional based in Framingham, MA. The role supports GXP activities and improves quality systems to ensure cGMP adherence and inspection readiness.

The position requires the ability to archive, organize, and maintain controlled documents, manage logbooks and batch records, and support audit activities. On-site 5-day workweek is typical.

Qualifications

• Bachelor's degree in a regulated manufacturing environment.
• 4+ years of relevant experience in quality systems.
• Experience with GDP and cGMP.
• Experience with MasterControl and Veeva is a plus.
• Strong writing and communication skills.

Responsibilities

• Archive, organize, and maintain controlled documents and records.
• Coordinate shipment, tracking, storage, and retrieval of documents to off-site archival facilities.
• Prepare, verify, and package controlled documents for off-site archival storage.
• Create, issue, and maintain logbooks, notebooks, and batch records.
• Manage document requests via Jira and provide customer support.
• Process, route, review, and maintain documents in MasterControl; format documents and create training.

Skills

Document control

Time management

Organizational skills

Communication

Microsoft Office

Problem solving

Teamwork

Education

Bachelor's degree in regulated manufacturing environment

Minimum 4 years of relevant experience

Tools

MasterControl

Veeva

Job description

Replimune Group, Inc. is seeking a Quality Systems Document Control professional based in Framingham, MA. The role supports GXP activities and improves quality systems to ensure cGMP adherence and inspection readiness.

The position requires the ability to archive, organize, and maintain controlled documents, manage logbooks and batch records, and support audit activities. On-site 5-day workweek is typical.