Today, Lonza is a global leader in life sciences operating across three continents. 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.
Lonza Bioscience has an exciting opportunity for a QA Specialist to join our team in Walkersville, MD. This individual will be responsible for all activities involving quality assurance and compliance with applicable regulatory requirements. We are looking for someone who has a wide degree of creativity and latitude as well as the ability to be independent and perform as an equal to the management team without having direct reports.
- Verification of the company’s compliance with ISO/cGMP quality system requirements as well as knowledge of 21CFR210, 211, 610 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1.
- Provide immediate support to operations and quality control staff to address compliance related concerns (QA “on-the-floor” support).
- Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams.
- Audit internal quality system elements in manufacturing and operational support areas
- Provide oversight for compliance of CA/PA and investigations, OOS and deviations
- Perform external audits of suppliers/vendors/off-site facilities.
- Act as a customer interface during on-site audits, conference calls and other standard means of communication.
- Independently identify and manage special projects or QA compliance functions as agreed upon with QA management
- Prioritize and manage a variety of projects simultaneously.
- May need to lead and direct the work of others.
- Review Device History Records (DHR) and Master Batch Records (MBR) and supporting documents. Perform review/release of batch records, as needed.
- Bachelor’s degree in life sciences required.
- Significant direct QA drug product experience required or an equivalent amount of aseptic processing and cell therapy manufacturing/product management experience.
- GMP compliance and Part 11 compliance knowledge preferred.
- Experience with oversight of aseptic processing and the associated international aseptic processing regulations.
- Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fastpaced environment; team oriented; independent work skills and a strong work ethic. The ability to interface and communicate directly with clients is required.
- Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.
- A strong sense of urgency to maintain project deadlines is required.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
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.