QA Raw Materials Compliance Specialist (2nd shift)

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 Raw Materials Specialist interacts directly with Lonza’s internal customers for disposition of materials.    These interactions will require frequent collaboration with these internal customers and will require the Specialist to frequently travel and work in those areas as needed. Using a deeper understanding of cGMP documentation, the Specialist will review material release documentation as well as other ancillary attachments such as vendor technical documentation, certificate of analysis/compliance and confirmatory test results, in order to ensure the timely release of raw material for production.  They will provide input on issues within their area of responsibility to Lead Specialists or management for resolution and/or improvements. The Specialist will also be expected to perform all associated SAP transactions as part of the release as well as other Quality functions within SAP.

Schedule for this role will be Monday-Friday 2nd shift (2pm-10:30pm)

Key responsibilities:

  • Review, manage and ensure compliance with GMP regulations for raw materials pertaining to commercial manufacturing
  • Serves as the SME for internal and external customers on technical transfers
  • Works with project teams to on-board raw materials
  • Update and revise SOPs as required to ensure compliance
  • Keeps up to date with compliance and regulation guidelines within the industry
  • Understands and makes informed decisions pertaining to testing and testing selections for materials

Key requirements:

  • Bachelor’s Degree, preferred area of study in biology, biochemistry or other science degree
  • Substantial experience working within a GMP regulated Biotech or Pharmaceutical industry
  • Significant knowledge of GMP regulations for commercial manufacturing as relevant to raw materials
  • Experience in testing and test selection raw materials
  • Experience supporting technical transfers desired
  • Ability to make independent decisions based off industry and regulations knowledge
  • Experience in on-boarding raw materials
  • Effective communication skills, written and verbal and the ability to partner and collaborate with partners from various functions
  • Able to prioritize and multi-tasks in a dynamic fast paced environment
  • Highly organized and detail oriented
  • Experience with SAP, Trackwise, LIMS, iLab or similar ERP system

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: R31583