Document Control and Records Management 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

Who We Are

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

Who We Are

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

THE ROSLINCT WAY

Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients.

ACCELERATING YOUR FUTURE

The Document Control and Records Management Specialist position is responsible for supporting the implementation of the Document Control Program and Records Management programs through timely archival and retrieval of controlled documents. This role may also support logbook and protocol issuance processes.

How You Will Make an Impact:

• Support record scanning and archival functions in compliance with site procedures


• Prepare documents for off-site storage


• Support verification of true copies/scans


• Preparation and maintenance of document templates


• Maintenance of the site glossary


• Maintain document inventory logs


• Support logbook issuance and reconciliation


• Support corrective actions and program enhancements as assigned


• Support document retrieval for regulatory inspections and client audits

What You Will Bring:

• Effective problem-solving capabilities.


• Strong oral and written communication skills.


• A highly organized work style that ensures timely execution of tasks.


• A mindset that ensures accurate results.


• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).

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

*This is an on-site position

Final compensation will be based on a variety of factors, including education, experience, technical expertise, specialized skill sets, market demand, internal equity, and business needs.

At RoslinCT, we offer more than just competitive pay. Our comprehensive Total Rewards package is designed to support your health, financial well-being, and professional development throughout your career.

Benefits include medical, dental, and vision insurance, educational assistance, a 401(k) program, and a variety of additional resources to help you thrive both personally and professionally.

• medical, dental, and vision insurance


• educational assistance


• a 401(k) program


• a variety of additional resources

OUR COMMITMENT

All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.

RoslinCT is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.