QA Specialist II-Lot review
LonzaPortsmouth, New Hampshire, United States
Posted March 24, 2026
Full Time
About the Company
At Lonza, our people are our greatest strength. We manufacture the medicines of tomorrow and offer equal employment opportunities to all qualified applicants.
Job Description
The QA Specialist II – Lot Review will support the accurate and timely review of manufacturing batch records and associated documentation to ensure compliance with GMP and regulatory requirements.
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
Benefits
- Performance-related bonus
- Medical, dental and vision insurance
- 401(k) matching plan
- Life insurance
- Short-term and long-term disability insurance
- Employee assistance programs
- Paid time off (PTO)