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Portsmouth, New Hampshire, United States
Onsite
QA Specialist II – Lot Review
Location: This position is based in our Portsmouth, NH office. The typical work schedule is Monday through Friday, 8:00 AM–5:00 PM EST.
What you will get:
Below you will find a comprehensive summary of the benefits package we offer:
Performance-related bonus.
Medical, dental and vision insurance.
401(k) matching plan.
Life insurance, as well as short-term and long-term disability insurance.
Employee assistance programs.
Paid time off (PTO).
Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.
What you will do:
The QA Specialist II – Lot Review is responsible for supporting the accurate and timely review of manufacturing batch records and associated documentation to ensure compliance with GMP and regulatory requirements. This role is highly detail-oriented and focused on the execution of batch record review and documentation accuracy.
Perform detailed review of manufacturing batch records and supporting documentation for completeness, accuracy, and compliance
Identify discrepancies, documentation errors, and GMP issues, and follow through to resolution
Escalate complex or unclear issues to senior QA team members as appropriate
Ensure all documentation aligns with Good Documentation Practices (GDP) and data integrity standards
Support timely batch disposition activities through efficient and thorough review
Participate in daily lot review/release meetings
Maintain clear and accurate documentation of review findings
Support audit and inspection readiness by ensuring records are complete and compliant
Collaborate with manufacturing and quality teams to clarify and resolve documentation issues
What we are looking for:
Bachelor’s degree in Life Sciences, Engineering, or a related field
3–5+ years of experience in a GMP-regulated environment within Quality Assurance or related function
Hands-on experience reviewing batch records and GMP documentation
Strong understanding of cGMP and Good Documentation Practices (GDP)
High attention to detail with a focus on accuracy and compliance
Ability to identify discrepancies and follow through on resolution
Strong organizational and time management skills
Effective communication skills and ability to work cross-functionally
Familiarity with data integrity principles and regulatory expectations
Experience supporting audits or inspections is a plus
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.
