ACCELERATING YOUR FUTUREThe Environmental Monitoring QC Manager oversees cleanroom and controlled environment testing in a cell and gene therapy CDMO. The Manager is responsible for leadership and oversight of the environmental monitoring team. They will manage monitoring staff, track microbial data trends, handle investigations and CAPAs (Corrective and Preventive Actions), and ensure compliance with cGMP and FDA standards. Responsible for writing/revising standard operating procedures (SOPs) and supporting equipment qualification and test method validation in compliance with all applicable quality systems and current cGMPs.
How You Will Make an Impact:- Manage routine viable/total particulate, air, surface, and gas testing in cleanrooms.
- Supervise, train, and mentor EM analysts and contractors.
- Review data tracking, trending reports, and environmental excursions in a timely manner.
- Lead investigations for environmental excursions, results, deviations, and write CAPAs.
- Host and support internal and external regulatory inspections (FDA, cGMP).
- Ensure data is accurate and up to date. This includes timely review of documents and cross functional coordination to meet timelines.
- Investigation and troubleshooting of equipment and associated test methods.
- Interact with various support departments to assist with scheduling of services performed in QC Microbiology.
- 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.
- Support implementation of information technologies that support documentation and data management systems.
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)
• 5 to 10+ years of cGMP pharmaceutical experience, 2 to 5 years of leadership experience, and expertise in cleanroom aseptic processing and global regulatory standards (FDA, EU Annex 1).
• Experience in a cGMP QC laboratory environment performing environmental monitoring, contamination control and investigation writing.
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.
Department Quality Control Locations Hopkinton Yearly salary $115,000 - $170,000 Employment type Full-time
