Sterility Assurance Expert - Quality Assurance
United States, Houston (Texas)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
The new state of the art Houston, TX facility is looking for a Sterility Assurance Manager. In this role you will be responsible for quality assurance oversight of Aseptic Processing Program, Environmental Monitoring and Microbial Control Policies for the Cell Therapy and/or Viral Therapy Operations. You will be expected to interact with Cell and Viral Therapy Operations Management, Quality Control and Quality Assurance leadership. Primary responsibility is to maintain sterility assurance of aseptically manufactured sterile drug products and viral vector products.
- Provide strategic plan and expertise for the development and implementation of the site Microbial Control Strategy.
- Develop, document and manage microbial control strategy for production processes from incoming raw materials through final product release.
- Provide oversight and sterility assurance expertise to Operations to assure aseptic processing meets US and international aseptic processing requirements.
- Assesses facility and quality systems’ state of compliance with internal requirements and appropriate regulations, and participates in the development of action plans to correct deficiencies and improve quality processes.
- Provides microbiological expertise to support EENs, deviations, CAPAs and Complaints related to aseptic processing.
- Supports regulatory and client audits as Aseptic sterility assurance subject matter expert.
- Provide microbiological and sterility expertise for cGMP documents including, but not limited to, SOPs, batch records, media fill/APS protocols and reports, validations and specifications.
- May manage a staff of 1 -2 specialists or provide guidance, oversight and support for Operations and QA/QC specialists.
- Bachelor’s Degree in Life Sciences
- Experience with regulations (US, EU and other)
- Experience in a biopharmaceutical manufacturing environment
- Experience in an aseptic manufacturing environment
- Biopharmaceutical manufacturing experience and/or aseptic processing working in a GMP environment
- Aseptic Processing
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.