Lonza
Today, Lonza is a global leader in life sciences operating across five continents. While we excel in science, our true magic lies in our talented team members who collaborate to devise innovative ideas that help businesses improve lives. At Lonza, we empower our employees to take charge of their careers, and we value ideas, big and small, that contribute to positive change in the world.
We are proud of our continuous growth and commitment to delivering world-class solutions in life sciences. We are currently seeking an ambitious
Senior Quality Assurance Specialist
to join our dedicated team in
New Hampshire, USA . This integral role in our Quality Compliance team is focused on driving continuous improvement to ensure full compliance with regulations and quality standards. As a Senior QA Specialist, you will work collaboratively across departments, mentoring colleagues and ensuring adherence to federal regulations and company procedures. This is your opportunity to make a tangible impact on our CGT Organization by successfully implementing and supporting Quality Systems. Key Responsibilities: Review and approve documents including SOPs, Master Batch Records, Work Instructions, Test Methods, Specifications, and other essential materials. Evaluate and approve Validation/Qualification documents such as Protocols and Summary Reports for various processes. Assess and approve non-DMS documents such as Preventative Maintenance records, CMMS forms, Instrument Data Sheets, and more. Analyze the potential impacts of document changes on regulatory and operational compliance. Review and endorse key Quality Management System (QMS) processes such as Deviations, CAPAs, Change Controls, and Investigations. Lead and facilitate meetings for the Deviation Review Board (DRB), Change Control Committee (CCC), and CAPA Board. Compile Quality metrics for use as Key Performance Indicators in Quality Council meetings. Oversee Lot Release activities and execute lot disposition when necessary. Provide audit and inspection support as a Subject Matter Expert. Represent Quality Assurance in meetings and on project teams. Mentor and train junior quality team members. Key Requirements: Exceptional written and verbal communication skills. Strong attention to detail with proven abilities in investigation and problem-solving. Demonstrated experience in reviewing and approving diverse documentation within Quality Systems. Ability to lead and mentor team members, ensuring compliance with regulations and procedures. Proven track record of compiling and analyzing Quality metrics. Capacity to evaluate the impact of document changes on compliance. Join us at Lonza AG and be part of our mission to enhance lives through your expertise and commitment. This is an exceptional opportunity to grow in a collaborative environment and contribute to our shared success! Every day, Lonza's products and services positively impact millions of lives. We understand that with this privilege comes great responsibility, and we are committed to achieving our business results ethically, respecting and protecting our people and the environment. At Lonza, we invite individuals who seek challenging and creative opportunities to solve complex problems and develop innovative ideas in the life sciences field. Together, we can make a meaningful difference in the world. 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, disability status, veteran status, or any other characteristic protected by law.
Senior Quality Assurance Specialist
to join our dedicated team in
New Hampshire, USA . This integral role in our Quality Compliance team is focused on driving continuous improvement to ensure full compliance with regulations and quality standards. As a Senior QA Specialist, you will work collaboratively across departments, mentoring colleagues and ensuring adherence to federal regulations and company procedures. This is your opportunity to make a tangible impact on our CGT Organization by successfully implementing and supporting Quality Systems. Key Responsibilities: Review and approve documents including SOPs, Master Batch Records, Work Instructions, Test Methods, Specifications, and other essential materials. Evaluate and approve Validation/Qualification documents such as Protocols and Summary Reports for various processes. Assess and approve non-DMS documents such as Preventative Maintenance records, CMMS forms, Instrument Data Sheets, and more. Analyze the potential impacts of document changes on regulatory and operational compliance. Review and endorse key Quality Management System (QMS) processes such as Deviations, CAPAs, Change Controls, and Investigations. Lead and facilitate meetings for the Deviation Review Board (DRB), Change Control Committee (CCC), and CAPA Board. Compile Quality metrics for use as Key Performance Indicators in Quality Council meetings. Oversee Lot Release activities and execute lot disposition when necessary. Provide audit and inspection support as a Subject Matter Expert. Represent Quality Assurance in meetings and on project teams. Mentor and train junior quality team members. Key Requirements: Exceptional written and verbal communication skills. Strong attention to detail with proven abilities in investigation and problem-solving. Demonstrated experience in reviewing and approving diverse documentation within Quality Systems. Ability to lead and mentor team members, ensuring compliance with regulations and procedures. Proven track record of compiling and analyzing Quality metrics. Capacity to evaluate the impact of document changes on compliance. Join us at Lonza AG and be part of our mission to enhance lives through your expertise and commitment. This is an exceptional opportunity to grow in a collaborative environment and contribute to our shared success! Every day, Lonza's products and services positively impact millions of lives. We understand that with this privilege comes great responsibility, and we are committed to achieving our business results ethically, respecting and protecting our people and the environment. At Lonza, we invite individuals who seek challenging and creative opportunities to solve complex problems and develop innovative ideas in the life sciences field. Together, we can make a meaningful difference in the world. 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, disability status, veteran status, or any other characteristic protected by law.