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.
At Lonza AG, we are exceptionally proud of our continuous growth and dedication to groundbreaking world-class solutions in life sciences. We are currently seeking an ambitious Sr. QA Specialist-3 to join our dedicated team in New Hampshire, USA. This role is integral to our Quality Compliance team, driving continuous improvement activities to ensure flawless adherence to all appropriate regulations. As a Sr. QA Specialist-3, you will collaborate closely across all departments, mentoring and driving compliance to federal regulations and company procedures. This is your chance to create a tangible impact on our CGT Organization by successfully implementing and supporting Quality Systems.

Key responsibilities:

• Review and approve initial and revised documents such as SOPs, Master Batch Records, Work Instructions, Test Methods, Specifications, Forms, Checklists, and others as needed.
• Review and approve electronic or paper Validation / Qualification documents such as Protocols and Summary Reports for CIP, SIP, Equipment / Instrumentation, Validation Maintenance, Computer Systems & Stability.
• Review and approve non-DMS documents such as Preventative Maintenance, CMMS forms, Instrument Data Sheets, Functional Equivalent Memos, DMS withdrawal forms, Periodic Review Audit Trail, and Miscellaneous Facility Forms.
• Determine possible impacts of document changes on regulatory and operational compliance.
• Review and approve key QMS processes such as Deviations, CAPAs, Change Controls, Investigations, and Efficiency Checks.
• Lead and chair DRB, CCC, and CAPA Board as required.
• Compile Quality metrics used as Key Performance Indicators for Quality Council.
• Review and approve Lot Release activities and perform lot disposition as required.
• Provide audits or inspection support, either as a Subject Matter Expert in front room or back room support.
• Represent QA in meetings or on project teams.
• Mentor and train other quality team members.

Key requirements:

• Excellent written and verbal communication skills.
• Strong attention to detail, with proven abilities in investigation and problem-solving.
• Proven experience in reviewing and approving various documents and protocols within Quality Systems.
• Ability to lead and mentor team members, driving compliance to federal regulations and company procedures.
• Strong track record of compiling and analyzing Quality metrics.
• Ability to determine the impact of document changes on regulatory and operational compliance.

Join us at Lonza AG and be a part of our mission to improve the world with your expertise and dedication. This is an outstanding chance to grow in a collaborative environment and contribute to our collective success!
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

• Review and approve initial and revised documents such as SOPs, Master Batch Records, Work Instructions, Test Methods, Specifications, Forms, Checklists, and others as needed.
• Review and approve electronic or paper Validation / Qualification documents such as Protocols and Summary Reports for CIP, SIP, Equipment / Instrumentation, Validation Maintenance, Computer Systems & Stability.
• Review and approve non-DMS documents such as Preventative Maintenance, CMMS forms, Instrument Data Sheets, Functional Equivalent Memos, DMS withdrawal forms, Periodic Review Audit Trail, and Miscellaneous Facility Forms.
• Determine possible impacts of document changes on regulatory and operational compliance.
• Review and approve key QMS processes such as Deviations, CAPAs, Change Controls, Investigations, and Efficiency Checks.
• Lead and chair DRB, CCC, and CAPA Board as required.
• Compile Quality metrics used as Key Performance Indicators for Quality Council.
• Review and approve Lot Release activities and perform lot disposition as required.
• Provide audits or inspection support, either as a Subject Matter Expert in front room or back room support.
• Represent QA in meetings or on project teams.
• Mentor and train other quality team members