Sartorius Quality Control Lead Job – Life Science Candidates Apply Now!
Join Sartorius as a Quality Control Lead in Marlborough, MA, overseeing environmental monitoring and QC microbiology at a GMP Phase 1 clinical production facility. This full-time role is ideal for candidates with 5+ years of QC experience, GMP expertise, and a passion for biotechnology and pharmaceutical quality control. Be part of a global leader in life sciences and biopharma—apply now!
Job Title: Quality Control Lead (Environmental Monitoring Program)
Location: Marlborough
Time Type: Full-time
Posted on: Posted 3 Days Ago
Job Requisition ID: R31734
Job Description
In the Quality Control Lead role at Sartorius, you will manage the QC activities essential to ensuring the quality and compliance of the new emerging therapy services, specifically at the GMP Phase 1 clinical production facility in Marlborough, MA. This includes focusing on novel modalities such as allogeneic stem cells, cell and gene therapy, and extracellular vesicles using advanced manufacturing methods.
What You Will Accomplish Together with Us
QC Microbiology:
- Oversee and execute microbiological testing
- Ensure compliance with cGMP regulations
Environmental Monitoring:
- Manage the environmental monitoring program
- Analyze data and implement corrective actions
Quality Metrics and Reporting:
- Establish and track QC metrics
- Compile and present QC reports
Quality Control Leadership:
- Provide leadership and support to the QC team
- Develop and implement SOPs and QC policies
Sample Control:
- Oversee Sample Control and instrument qualification
- Manage external QC sample requisition and testing
What Will Convince Us
What will convince us:
- You have completed a bachelor’s degree in a Biology, Microbiology, Chemistry, Biochemistry, or a related scientific field.
- Completion of master’s degree or PHD in a Life Sciences discipline a plus.
- You have a minimum of 5+ years of experience in a QC role within the biotechnology or pharmaceutical industry, with at least 1 years in a leadership or supervisory capacity preferred.
- Extensive knowledge of cGMP regulations and experience with QC testing in a biotechnology manufacturing environment.
- Demonstrated expertise in Sample Control, instrument qualification, assay validation, method qualification, QC Microbiology, QC analytical testing, and environmental monitoring.
- Up to 10% domestic and international trav
Work Environment
The QC Lead will work in a controlled laboratory setting that requires adherence to safety protocols and cGMP regulations. The role may involve exposure to chemicals, biological materials, and controlled environments, necessitating the use of personal protective equipment.
What We Offer
As a growing global life science company, Sartorius offers personal and professional development, work-life balance, a welcoming culture, health & well-being support, an intelligent working environment, a retirement savings plan, and more.
If you are passionate about contributing to advancements in global healthcare, don’t miss this opportunity to join our team.
Keywords: Quality Control Lead, Sartorius, Environmental Monitoring Program, Biotechnology, Pharmaceutical, GMP, Regulatory Compliance, QC Microbiology, Quality Metrics, Sample Control
