Sr Analyst, Compliance Specialist - QC Microbiology

About the role

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.

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.

Benefits

• Medical, dental, and vision insurance
• Educational assistance
• 401(k) program
• A variety of additional resources to help you thrive both personally and professionally