Quality Assurance Specialist

United States, Walkersville (Maryland)

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's media manufacturing facility is one of the largest in the world and our facility is growing. We are looking for professionals to grow with us and we have exciting opportunities in the Quality Assurance group. The QA Specialist verifies the company’s compliance with ISO/GMP quality system requirements and other regulatory guidance as appropriate; reviews Device History Records (DHR) and Master Batch Records (MBR) and supporting documents; audits internal quality system elements in manufacturing and operational support areas; and provides oversight for compliance of CAPA and investigations. This position may need to lead without authority at times, offering back-up assistance to supervisors and driving accountability in teams.

Key responsibilities:

  • Verifies the company’s compliance with ISO/cGMP quality system requirements as well as Good Manufacturing Practices for Human and Veterinary use
  • Provides immediate support to operations and quality control staff to address compliance related concerns
  • Makes independent quality-related decisions based on regulatory and compliance knowledge
  • Audits internal quality system elements in manufacturing and operational support areas
  • Provides oversight for compliance of CAPA and investigations, OOS and deviations
  • Leads asset-specific continuous improvement and adhoc projects and supports asset-specific gap analyses/mitigation efforts
  • Performs other duties as assigned

Key requirements:

  • Bachelor’s degree required; Life sciences degree, preferred
  • Advanced experience in the Quality Operations Field
  • GMP Commercial experience and/or bio-pharmaceutical experience preferred
  • Experience with change control and supplier qualification
  • Prior experience with quality functions, aseptic techniques, GDP/GMP requirements, material release, investigation skills
  • Proficient in the use of spreadsheets, databases, and word processing software
  • Prior experience with SAP, Trackwise and LIMS are a plus
  • Able to propose ideas during problem solving, root cause analysis, and process improvement events

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.

Reference: R43358