GMP Document Control & Records Specialist

RoslinCT; Hopkinton (MA); On-site; USD 65,000 - 87,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Educational assistance

401(k) program

A variety of additional resources

Job summary

RoslinCT, a world-leading cell and gene therapy CDMO, is seeking a Document Control and Records Management Specialist to safeguard controlled documents and support regulatory readiness onsite in Hopkinton, MA. You will help implement the Document Control Program, manage archival processes, and maintain templates and logs while collaborating with QA and operations to ensure timely, compliant documentation.

This on-site role offers exposure to GMP environments, with benefits package and

Qualifications

• 0-2+ years working in a regulated GMP environment.
• Prior experience in document control and records management a plus.
• Ability to work independently to meet objectives and timelines.
• Experience in 21 CFR Part 210/211 and 21 CFR Part 11; familiar with ICH regulations/ guidelines a plus.
• Experience in Adobe, Microsoft Excel, and Microsoft Word.

Responsibilities

• Support the implementation of the Document Control Program and Records Management processes.
• Assist with archival and retrieval of controlled documents.
• Support logbook issuance and regulatory document workflows.
• Maintain document templates and site glossary.
• Assist with inspections and client audits preparations.
• Contribute to corrective actions and program enhancements.
• Maintain document inventory logs.

Skills

Problem-solving

Communication skills

Organized work style

Attention to detail

Tools

Adobe

Microsoft Excel

Microsoft Word

PowerPoint

Job description

RoslinCT, a world-leading cell and gene therapy CDMO, is seeking a Document Control and Records Management Specialist to safeguard controlled documents and support regulatory readiness onsite in Hopkinton, MA. You will help implement the Document Control Program, manage archival processes, and maintain templates and logs while collaborating with QA and operations to ensure timely, compliant documentation.

This on-site role offers exposure to GMP environments, with benefits package and