Sr. QC Analyst, Microbiology
About The Position
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. 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.
Requirements
- Bachelor’s degree in Biology (Microbiology)
- 4+ years of microbiology laboratory experience with rapid microbiological methods is a plus (rapid sterility, endotoxin, gram stain).
- Experience in a cGMP QC laboratory environment performing environmental monitoring, contamination control and investigation writing.
- Excellent/Effective written and verbal communications skills.
- Prepare technical data and present to senior leadership.
- Escalate issues professionally and on a timely basis.
Nice To Haves
- rapid microbiological methods (rapid sterility, endotoxin, gram stain)
Responsibilities
- Participate as microbiology method subject matter expert (SME) in investigations, OOS, deviation, change controls, and CAPAs to support cGMP operations.
- Author, review, approval, and final authorization of microbiology methods (test results and records, test methods) and ensuring adherence to regulatory agency requirements, Client standards, policies, SOPs for cell therapy products and experience with EU Annex requirements.
- Analyzes data to identify and resolve contamination control issues, maintains documentation, and collaborates with cross-functional teams to support and improve contamination control strategies.
- Provide training to QC and MFG as a contamination SME: develop training approach, training documents and provide training for new methods.
- Execute procedures for microbiology methods in support of method lifecycle activities including method transfer, qualification, validation, compendial verification, and performance monitoring.
- Perform non-routine/routine QC testing for in process samples, product testing, stability testing, or raw material testing as needed.
- Work collaboratively with cross functional departments including but not limited to QC Technical Services, Quality Assurance, and Program Management.
- Ability to prepare technical data and present to senior leadership.
Benefits
- flexible and empowering work environment
- attractive benefits package
- emphasis on work-life balance
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What This Job Offers
Job Type
Full-time
Career Level
Senior
