QA Specialist II-Raw Materials Compliance (Biotech)

 

Today, Lonza is a global leader in life sciences operating across five 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.

Seeking a dedicated QA Specialist II to uphold Raw Material compliance. Join Lonza AG's team in New Hampshire, USA for a vital role in product quality and success! This role provides QA compliance support for the receipt and release of raw materials. The position provides oversight of logistics, warehouse, and dispensing to ensure availability of materials for Production. Support for supplier management, supply chain, vendor changes and raw material release is also provided. Without this position there will be a lack of released raw materials for use in production at the site resulting in Production schedule interruptions.

Key responsibilities:

• Perform all associated SAP transactions and other Quality functions within SAP to support the Raw Material lifecycle, ensuring timely material release for production.
• Provide on-the-floor support for Raw Material requests, including inspection, assessment, labeling, and related processes.
• Review material documents for disposition to support timely release with minimal mentorship.
• Approve initial and revised documents for Raw Material lifecycle in the Document Management System (DMS), including SOPs, Work Instructions, Forms, Checklists, Specifications, Scanned Documents.
• Review and approve electronic and paper Validation/Qualification documents, including Protocols & Summary Reports for Equipment/Instrumentation, Validation Maintenance, and relevant Computer Systems.
• Review and approve various record types in a Quality Management System (e.g., TrackWise) with minimal direction, including Investigations, Change Controls, CAPAs, Deviations, and other records as needed.

Key requirements:

• Proven experience in Quality Assurance, specifically in Raw Material Compliance.
• Strong understanding of cGMP documentation review, approval, and release processes.
• Ability to work independently and resolve sophisticated quality issues by referencing appropriate procedural documentation.
• Teamwork skills, particularly with Supply Chain, Quality Control, and Manufacturing departments.
• Outstanding attention to detail and strong coordination abilities.
• Proficiency in SAP and Document Management Systems.
• Bachelor's degree in a related field or equivalent experience.

Join us in our quest to deliver outstanding life sciences solutions and make a real impact on millions of lives!

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.