QA Coordinator

Job Title: Senior Quality Compliance Specialist About Us Lonza is a global leader in life sciences, operating across three continents. Our greatest scientific solution is talented people working together to devise ideas that help businesses and ultimately improve the world. Job Summary We are seeking a dedicated and hardworking Senior Quality Compliance Specialist to join our team in New Hampshire, USA. This is an outstanding opportunity to become part of an exceptional organization that values flawless execution and a collaborative spirit. Key Responsibilities Apply a standard to independently review and approve initial versions and revised documents within the Document Management System (DMS), including SOPs, Master Batch Records, Work Instructions, Test Methods, Specifications, Forms, Checklists, and Scanned Documents. Review and approve electronic/paper Validation and Qualification documents, including Protocols and Summary Reports for CIP, SIP Equipment/Instrumentation, Validation Maintenance, Computer Systems, and Stability. Approve non-DMS documents, such as QA Monthly Preventative Maintenance, Engineering Preventative Maintenance documents, CMMS Forms, Instrument Data Sheets, and Facility Forms. Evaluate document changes to determine their impact on regulatory and operational compliance. Provide detailed document review observations and suggested edits/comments. Follow Lonza's documentation review procedures ensuring changes are justified and accurately reflected. Partner with internal customers as the Quality Subject Matter Expert for Documentation Changes & Review. Support departmental projects, including PQR reports and interim data analysis. Attend meetings well-prepared to discuss projects/changes and identify quality requirements, defining the path forward for Documentation revision. Lead departmental projects by defining project plans, scope, and deliverables. Requirements Bachelor's Degree 5-10 years of experience Preferred knowledge of GMP regulations (e.g., ICH Q7-Q11, CFR 210, 211, 600-680, 820, etc.) Outstanding written and verbal communication skills, proficient in Microsoft Office Tools (e.g., Word, Excel, Outlook, PowerPoint) Experience with enterprise systems such as DMS, LIMS, TrackWise, SAP, Syncade Driven and goal-oriented, with the ability to manage demanding workloads and adapt to changing priorities, while paying attention to detail. Effective both independently and in a team environment About Us Lonza respects and protects its people and the environment. Any success we achieve is no success at all if not achieved ethically. We value the creativity of solving complex problems and developing new ideas in life sciences. Lonza is an equal opportunity employer, committed to diversity and inclusion. 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.

Created: 2025-03-04