Senior QA 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 Walkersville is IMMEDIATELY HIRING a Senior QA Associate or Specialist to audit internal quality systems, review Master Batch Records and Device History Records. The Senior QA Associate or Specialist will serve as a backup to Quality Systems Manager. 

Key responsibilities:

  • Audits internal quality system elements in manufacturing and operational support areas.
  • Provides oversight for compliance of CAPA and investigations, OOS and deviations.
  • Reviews and approves batch records, deviations, change controls and CAPAs.
  • Leads and directs at least one quality review board, include action item follow-up, tracking of metrics/KPIs, agenda setting, and using judgement to drive follow up. 

Key requirements:

  • High School Diploma or GED required; Bachelor’s degree in the life sciences, preferred.
  • Minimum of 7 years of direct Quality Assurance experience from a similar biotech, medical or clinical GMP environment required;
  • Significant working experience with Quality Systems required.
  • Strong technical writing and reviewing skills required.
  • Experience interacting with FDA or other regulatory agencies, preferred.
  • SAP experience is a plus.

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: R56270