Sr Analyst, Compliance Specialist - QC… at RoslinCT · Hopkinton

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

A Senior Analyst or Compliance Specialist in Quality Control (QC) Microbiology oversees microbial testing, environmental monitoring, and regulatory compliance in pharmaceutical and biotech manufacturing. They ensure testing data integrity, manage deviations, and act as subject matter experts during audits.

How You Will Make an Impact:

· Ensure data is accurate and up to date. This includes timely review of documents and coordination with other organizations to meet timelines.

• Perform or review endotoxin, sterility, growth promotion and routine testing alongside cleanroom environmental monitoring.

· Identification and implementation of process improvements.

· Development of processes that will support staff and department evaluation and growth

· Ensure that work is completed in accordance with requirements including but not limited to CFR's, cGMPs, SOPs, and company policies.

· Ensure cGMP compliance and maintain quality standards for all manufacturing activities.

· Initiate plans and processes which minimize costs through effective utilization of manpower

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

· Participate and lead in investigations, change controls and CAPAs.

What You Will Bring:

• Excellent/Effective written and verbal communications skills.
• Prepare technical data and present to senior leadership.
• Escalate issues professionally and on a timely basis.
• Ability to adhere to timelines for testing and reporting of data
• Ability to function in a team-oriented environment
• A highly organized work style that ensures timely execution of tasks.
• A mindset that ensures accurate results.
• Effective problem-solving capabilities.

Qualifications:

· Bachelor’s degree in biology (Microbiology), Biology, or a related life science.

· 4 to 6+ years of GMP laboratory experience within a sterile or biotech environment.

· Experience with data review in a cGMP QC laboratory environment performing environmental monitoring, rapid microbiological methods (rapid sterility, endotoxin).

· Strong working knowledge of USP, cGMP, FDA, and data integrity guidelines.

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.