QA Specialist III-Lot Review

QA Specialist III – 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 Lot Review Specialist III plays a key role in ensuring the quality and compliance of manufacturing operations by leading the review and release of production documentation for Active Pharmaceutical Ingredients (API). This position combines deep GMP knowledge with strong project management skills, supporting both day-to-day batch release activities and broader quality initiatives. As a senior member of the team, you’ll work cross-functionally, help drive process improvements, and mentor junior staff while ensuring alignment with regulatory expectations and internal quality standards.

• Independently review and approve manufacturing batch records and supporting documentation to enable timely product release

• Lead resolution of documentation issues, including more complex deviations, and escalate when appropriate

• Participate in daily lot release meetings and collaborate with cross-functional teams to ensure alignment on priorities

• Apply GMP, Good Documentation Practices, and data integrity principles across all work

• Support and lead quality-related projects, including process improvements and efficiency initiatives

• Provide guidance, training, and mentorship to junior team members

• Contribute to continuous improvement of quality systems and review processes

• Support audit and inspection readiness activities as needed

• Manage multiple priorities while maintaining high attention to detail and compliance standards

What we are looking for:

• Bachelor’s degree in Life Sciences, Engineering, or a related field

• 5–8+ years of experience in a GMP-regulated environment within Quality Assurance or a related function

• Strong working knowledge of cGMP regulations and quality systems

• Experience with batch record review and product release processes

• Demonstrated ability to manage projects and drive process improvements

• Strong problem-solving skills with the ability to assess and resolve complex issues

• Effective communication skills and ability to collaborate across teams

• Experience mentoring or training junior staff

• Familiarity with data integrity principles and regulatory expectations

• Experience supporting audits and inspections is 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.