QA Specialist II-Lot review

About the role

The QA Specialist II – Lot Review is based in Portsmouth, NH and works Monday through Friday from 8:00 AM to 5:00 PM EST.

Responsibilities

• Support the accurate and timely review of manufacturing batch records and associated documentation to ensure compliance with GMP and regulatory requirements.
• 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.

Requirements

• 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.

Qualifications

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).

Skills

Not specified.

Benefits

Not specified.

Pay

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

Schedule

The typical work schedule is Monday through Friday, 8:00 AM–5:00 PM EST.

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.

Reference

R74861