QA Specialist III-Lot Review
Lonza • Portsmouth, New Hampshire, United States
Role & seniority: QA Specialist III (onsite), Portsmouth, NH
Stack/tools: cGMP environment; TrackWise; SAP; Microsoft Office
Top 3 responsibilities
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Review and close manufacturing batch records and related documentation for API release
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Resolve issues and escalate complex cases; participate in daily lot release meetings and routine QA activities
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Train junior staff on record review processes; apply data integrity principles; support process improvement initiatives; collaborate with QA/QC/Manufacturing
Must-have skills
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Bachelor’s degree in Science or related field
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5–10 years in cGMP environments; strong quality systems and good documentation practices
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Excellent attention to detail, critical thinking, and communication (written and verbal)
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Ability to work independently and in a team; proficient in Microsoft Office
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TrackWise and SAP experience preferred
Nice-to-haves
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Experience with data integrity principles; process improvement project involvement
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Formal training/experience in QA record review and batch release processes
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Location & work type: Onsite at Lonza facility in Portsmouth, NH; full-time role
Note: Role focuses on ensuring API release readiness and compliance within a collaborative QA/QC/Manufacturing context.
Full Description
QA Specialist III – Lot Review Location: Onsite at our Portsmouth, NH facility Join our Quality Assurance team in Portsmouth, NH, where you’ll play a critical role in ensuring the integrity and compliance of our manufacturing processes. This is an exciting opportunity to contribute to the release of life-changing therapies while developing your skills in a collaborative environment. What you will get: An agile career and dynamic working culture An inclusive and ethical workplace Compensation programs that recognize high performance Medical, dental, and vision insurance Opportunities for professional growth and leadership development Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits What you will do: Review and close manufacturing batch records and related documentation for API release Resolve issues and escalate complex cases when needed Participate in daily lot release meetings and routine QA activities Train junior staff on record review processes Apply data integrity principles in all aspects of work Support process improvement projects and quality initiatives Collaborate with QA, QC, and Manufacturing teams to maintain compliance What we are looking for: Bachelor’s degree in Science or related field 5–10 years of experience in cGMP environments Strong knowledge of quality systems and good documentation practices Excellent attention to detail and critical thinking skills Effective written and verbal communication skills Ability to work independently and within a team environment Proficiency in Microsoft Office; experience with Trackwise and SAP preferred About Lonza: At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences? Apply now.