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QA Raw Materials Compliance Specialist-Tech Transfers

  • Permanent
  • Anywhere

Website Lonza

Lonza

Company : Lonza

Country: United States

Location : Portsmouth, New Hampshire

Post: Mon, 30 Jan 2023 20:00:44 GMT

Expires: Mon, 27 Feb 2023 23:59:59 GMT

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—————————— Job Description ——————————

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 Raw Materials Compliance Specialist – Tech Transfers is assigned as the primary liaison to Technology Transfer Teams. The QA Raw Materials Compliance Specialist – Tech Transfers 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 Raw Materials Compliance Specialist – Tech Transfers will participate in internal and joint quality meetings regarding materials tech transfer that include Lonza Customer representatives and other Lonza site personnel. The QA Raw Materials Compliance Specialist – Tech Transfers will use their regulatory and technical knowledge to assist the technology transfer teams in trouble shooting issues for raw materials. QA Raw Materials Compliance Specialist – Tech Transfers will also be responsible for handling raw material specifications / documents edits, reviewer and approver responsibilities as applicable. The QA Raw Materials Compliance Specialist – Tech Transfers interacts directly with Lonza’s internal and external customers on Technology Transfer Projects for the onboarding of raw materials.

Responsibilities

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 project team as part of Internal project meetings serving as the Quality Subject Matter Expert for any raw material discussions.
Generate, Edit, Review and Approve material specification / GMP documents as applicable
Perform other duties as assigned.

Key Requirements:

High School Diploma, Bachelor’s Degree preferred.
Working knowledge of the applicability of ICH Quality Modules (ICH Q7,
Working Knowledge of the United States Pharmacopeia, European Pharmacopoeia, Japanese Pharmacopoeia.
Full understanding of Material Attribute requirements such as (not all inclusive):
BSE/TSE
Allergens
Leachable Extractables
Proper Storage conditions
Physical attributes of a material and impact on process.
Ability to balance and prioritize tasks
Willingness to ask questions and/or to seek input from more experienced peers and management
Ability to maintain and build internal and external relationships, works effectively individually and with teams
Questioning attitude and critical thinking
Displays a clear willingness to listen to others
Demonstrates quality decision making
Self-starter
Solid written and verbal communication, good attention to detail

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: R49766

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