Quality Systems Specialist — GMP & Documentation Expert

Replimune; Framingham, Northern (MA, KY); Hybrid; USD 102,000 - 132,000; 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 detail‑oriented QA Document Specialist to support GXP activities and improve Quality Systems. This role helps ensure cGMP readiness by managing controlled documents, training, audits, and cross‑functional collaboration across sites.

Responsibilities include archival document control, MasterControl administration, and participation in internal audits. Bachelor’s in a regulated setting and 4+ years of experience are required.

Qualifications

• Bachelor's degree in a regulated manufacturing environment or equivalent experience.
• Minimum of 4 years of relevant experience.
• Experience with electronic document management systems preferred (MasterControl, Veeva).

Responsibilities

• Archive and maintain controlled documents in compliance with GDP.
• Coordinate shipments to off-site archival facilities.
• Prepare and package documents for archival storage.
• Create, issue, and maintain logbooks and batch records.
• Manage document requests via Jira and provide customer support.
• Maintain MasterControl DMS, user access, and workflows.
• Assist with onboarding training on quality procedures.
• Participate in internal audits and metrics.
• Support OMS metrics and quality improvement initiatives.
• Collaborate across departments to ensure audit-ready records.

Skills

Time management

Organization

Problem solving

MS Office

Communication

Ethical

Physical ability

Education

Bachelor's degree in regulated manufacturing

Tools

MasterControl

Veeva

Job description

Replimune is seeking a detail‑oriented QA Document Specialist to support GXP activities and improve Quality Systems. This role helps ensure cGMP readiness by managing controlled documents, training, audits, and cross‑functional collaboration across sites.

Responsibilities include archival document control, MasterControl administration, and participation in internal audits. Bachelor’s in a regulated setting and 4+ years of experience are required.