QA Raw Materials Project Manager - Hybrid

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 QA Project Manager Raw Materials is assigned as the primary liaison to Technology Transfer Teams.  The QA Project Manager Raw Materials will be a technical and quality resource for the Project teams to include: Project Management, Quality Control Technical Services and Materials Science and Technology associates. QA Project Manager Raw Materials will participate in internal and joint quality meetings regarding materials tech transfer that include Lonza Customer representatives and other Lonza site personnel.   The QA Project Manager Raw Materials will use their regulatory and technical knowledge to assist the technology transfer teams in trouble shooting issues for raw materials. QA Project Manager Raw Materials will also be responsible for handling raw material specifications / documents edits, reviewer and approver responsibilities as applicable. The QA Project Manager Raw Materials interacts directly with Lonza's internal and external customers on Technology Transfer Projects for the onboarding of raw materials.

Responsibilities

  • Partner with internal functional areas as part of the change control process.

  • Support the Deviation, Investigation, and CAPA processes specific to their assigned customers; review and approve investigation reports including root cause analysis and assure corrective and preventive actions address the root cause to prevent recurrence

  • Interact with internal and external customer as part of Joint and Internal project Teams serving as the Quality Subject Matter Expert for any customer related quality issues.

  • Track and present customer metrics.

  • Review and approve various product specific documents such as Quality Agreements, Product Quality Reviews etc.

  • Support customer audits.

  • Perform other duties as assigned.

Key Requirements:

  • High School Diploma, Bachelor’s Degree preferred.

  • Participate in Technology Transfer Teams to support the onboarding of Raw Materials by:

    • Assisting in the development of appropriate testing matrixes

    • Assisting in the proper selection of materials for the given process

    • Providing knowledge to the process team regarding ICH, Compendial and regulatory expectations for raw material compliance

    • Review and Approval of vendor documentation

      • Where gaps are noted assist with appropriate Risk Assessments

      • Provide guidance based on knowledge of materials and Regulatory requirements

  • Support the Deviation, and Change Control through assessment and participation in team events

  • Review of Technical Reports regarding raw materials to include

    • Testing Matrixes

    • Leachable Extractable reports

    • Risk analysis

    • BSE/TSE Statements

  • Interact with internal and external customer as part of Joint and Internal project Teams serving as the Quality Subject Matter Expert for any customer related raw material discussions.

  • Generate, Edit, Review and Approve material specification / GMP documents as applicable

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: R48627
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