QC Associate Project Manager

United States, Portsmouth (New Hampshire)

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.

The QC Associate Project Manager will work on redevelopment of the QC Raw Material specification creation and ownership within QC Portsmouth. They will create a project plan for each incoming raw material, work with appropriate Scientists to understand the testing needs, write the specification and ensure Quality compliance with QA. The Project Manager will also work on compiling portions of Product Quality Review documents regarding Raw Materials and BDS. Technical writer of specifications and possibly other quality documents such as validation protocols or reports. Excellent communication skills in a cross-functional team. Comfortable working and communicating with highly technical individuals.

Key Responsibilities:

  • Perform project management and identifying QC responsibilities as pertaining to transfers and validations.
  • Use of Microsoft project or similar planning tool is highly desirable
  • Project work to be performed and timelines pertaining to area of responsibility
  • Act as writer of Raw Material specifications and monographs within the department
  • Ensuring multi-compendial compliance (USP/EP/JP) alongside technical SME
  • Use Statistical software to pull trending charts for compilation of product quality reports.
  • Understand regulatory requirements and Lonza policies pertaining to the area of responsibility
  • Ensure applicable Quality Control policies or procedures are appropriate and establish and/or revise as necessary

Key Requirements:

  • Bachelor or Advanced Degree (MS Preferred)- area of study: Chemistry, Biochemistry, or equivalent scientific field
  • Technical writing capabilities highly desirable
  • Intermediate level of experience for a GMP/Professional environment
  • Entry level experience in project management
  • Very solid understanding of Raw Materials as pertaining to a Manufacturing facility
  • Working understanding of Statistics is highly desirable
  • Experience in statistical software - keen attention to detail and quality
  • Ability and comfort working independently, able to manage multiple projects at once

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: R32672