Quality Systems Specialist – Doc Control & Compliance

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

Benefits offered by this job

Medical, dental, vision insurance

401k match

Paid holidays and time off

Job summary

Replimune Group is seeking a Quality Systems/Document Control professional to support cGMP compliance. Based in Framingham, MA, the role focuses on archiving and maintaining controlled documents, coordinating archival shipments, and ensuring GDP-aligned processes.

You will manage MasterControl and assist with training, audits, and continuous improvement of the quality system. This on-site position requires strong organizational skills, exceptional attention to detail, and the ability to

Qualifications

• Highly motivated with excellent time management.
• Strong organizational skills with ability to prioritize multiple projects.
• Excellent written and oral communication skills.
• Experience with regulatory quality systems is a plus.
• Ability to lift boxes <15lbs.

Responsibilities

• Archive, organize, and maintain controlled documents per quality/regulatory requirements.
• Coordinate shipment, tracking, storage, and retrieval of off-site archival documents.
• Prepare, verify, and package controlled documents for off-site storage.
• Create, issue, and maintain logbooks, notebooks, and batch records.
• Manage document requests via Jira and ensure timely responses.
• Maintain MasterControl documents, including formatting and training curricula.

Skills

Time management

Organizational skills

Communication

Problem solving

Attention to detail

Education

Bachelor's degree in a regulated manufacturing environment or equivalent experience

Tools

MasterControl

Veeva

Microsoft Office

Job description

Replimune Group is seeking a Quality Systems/Document Control professional to support cGMP compliance. Based in Framingham, MA, the role focuses on archiving and maintaining controlled documents, coordinating archival shipments, and ensuring GDP-aligned processes.

You will manage MasterControl and assist with training, audits, and continuous improvement of the quality system. This on-site position requires strong organizational skills, exceptional attention to detail, and the ability to