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

The Quality Control Analyst will be responsible for collection of environmental and raw material samples, sample management activities, and testing of cell therapy in-process, release and stability product samples. He/she will be responsible for reporting of data and writing/revising standard operating procedures (SOPs). He/she may support equipment onboarding and qualification as well as test method qualification in compliance with all applicable quality systems and current cGMPs.

How You Will Make an Impact:

· Conduct routine and non-routine analyses of samples for in-process, final product, stability, raw materials, and environmental samples.

· Execute sampling and QC Sample Management activities per procedure or written protocols.

· Perform environmental monitoring of cleanrooms and controlled areas

· Complete documentation for QC testing activities including data reports, reagent preparation, equipment logs and inventory logs.

· Write/revise QC specific procedures and protocols for newly built Cell Therapy manufacturing facility.

· Support implementation of information technologies that support documentation and data management systems.

· May participate in investigations, change controls and CAPAs.

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:

· Certificate in Biotechnology or bachelor's degree in scientific discipline preferred

· 0-7+ years' experience in manufacturing environment

· Familiarity/experience in a cGMP QC laboratory is desirable

· Ability to adhere to timelines for testing and reporting of data

· Ability to function in a team-oriented environment

· Experience with environmental monitoring working in an Aseptic Processing manufacturing facility is a plus

· Excellent/Effective written and verbal communications skills

· Adhere to scheduled timelines while maintaining flexibility and attention to detail

· Ability to work in a fast-paced, collaborative environment and able to manage workload based on changing priorities

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.

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