Lonza
QA Specialist II-Lot review
US - Portsmouth, NH · Mid
Sponsorship not specifiedDetected 13 days ago
GMPCommunicationCollaborationTime Management
About the role
- 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.
- With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow.
Responsibilities
- Perform detailed review of manufacturing batch records and supporting documentation for completeness, accuracy, and compliance
- Support timely batch disposition activities through efficient and thorough review
- 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
- Strong understanding of cGMP and Good Documentation Practices (GDP)
- Ability to identify discrepancies and follow through on resolution
- Effective communication skills and ability to work cross-functionally
- Familiarity with data integrity principles and regulatory expectations
Nice to have
- Experience supporting audits or inspections is a plus
Compensation
- Compensation for this role will be determined by the candidate's qualifications, skills, experience, and relevant knowledge.
Benefits
- Performance-related bonus.
- Medical, dental and vision insurance.
- Life insurance, as well as short-term and long-term disability insurance.
- Paid time off (PTO).
Company info
- What we are looking for:
- 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.
- If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.
This listing is sourced directly from Lonza's careers page and normalized into a canonical job model.