GMP Support Associate

RoslinCT US; Hopkinton (MA); On-site; USD 42,000 - 62,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) program

Educational assistance

Job summary

RoslinCT is seeking a GMP support professional to oversee cleaning operations in classified environments and ensure adherence to cGMP and SOPs. The role involves ordering, movement, and inventory of GMP materials, with cross-functional collaboration to ensure timely access to controlled areas.

Ideal candidates have 0-2 years in GMP settings, strong Microsoft Office proficiency, and ability to adapt in a fast-paced environment.

Qualifications

• 0-2 years of experience in a GMP-regulated environment.
• Proficient in Word, Excel, and PowerPoint; familiarity with manufacturing/quality systems.
• Ability to work in a fast-paced environment with minimal direction.

Responsibilities

• Support cleaning operations in classified and non-classified environments.
• Ensure activities comply with cGMP, SOPs and regulatory expectations.
• Coordinate with Supply Chain and Manufacturing to maintain inventory and material readiness.
• Perform GMP-compliant kitting and traceability.
• Assist with cross-functional timing to access classified areas.

Skills

Oral and written communication

Organizational skills

Problem-solving

Tools

Microsoft Word

Excel

PowerPoint

Manufacturing systems

Quality systems

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.

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

Reporting to the Supervisor, GMP Support, this role supports and ensures that all cleaning activities are performed consistently, safely, and in alignment with current Good Manufacturing Practices (cGMP) and internal requirements. Responsible for ordering, movement, and inventory of GMP materials (e.g., cleaning, and process related materials). Collaborate with Manufacturing, Supply Chain/Operations, and the Facilities team to ensure timely access to the controlled areas, and materials.

How You Will Make an Impact:

• Responsible for the cleaning operations in classified and non-classified environments (e.g., Grade B-D, CNC)
• Ensure all cleaning activities comply with cGMP, SOPs, and regulatory expectations
• Orders, moves, and ensures the manufacturing inventory and kitting of GMP materials.
• Perform and verify GMP-compliant kitting of materials for use in classified areas
• Performs GMP kitting activities, maintaining traceability, status labeling, and the appropriate segregation.
• Coordinate with Supply Chain and Warehouse teams to maintain adequate stock levels and avoid shortages
• Coordinate timing with cross-functional teams on the availability of the classified areas
• Other duties as assigned.

What You Will Bring:

• 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).
• Effective problem-solving capabilities.
• Strong oral and written communication skills.

Qualifications:

• 0-2 years of experience in a GMP-regulated environment
• Skilled in Microsoft Word, Excel, and commonly used Manufacturing and Quality systems (preferred)
• Comfortable in a fast-paced and dynamic environment with minimal direction and able to adjust workload based upon changing priorities

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.

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.