GMP Specialist

United States, Rochester (New York)

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 Opportunity:

Great opportunity for a GMP Quality Specialist!  Lonza Rochester produces biocides and personal care ingredients for the hygiene, preservation and personal care markets. 

Summary:

The GMP Compliance Specialist is the primary coordinator for all site activities related to compliance with local and GROUP quality procedures. Activities include managing the internal audit program and supervising the Document Control specialist activities.
 

Description:

  • Perform regular “shop floor” inspections of manufacturing, maintenance, QC, warehousing facilities. 
  • Lead audits with FDA, customers and internal groups
  • Provide coaching and training for employees with regard to GMP/quality.
  • Ensure annual internal quality audit plan is issued and executed. 
  • Provide supervisory oversight for the site Document Control Specialist. 
  • Perform other duties as assigned.

Qualifications:

  • 5 years of experience in a GMP environment
  • BS degree in a scientific discipline is preferred or AS degree with 7 years of experience.
  • Experience working in a Quality Compliance capacity
  • Experience participating in audits with customers and FDA

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: R20964