Senior QA Specialist - Operations
Location: This position is based in our Portsmouth, NH office. The standard schedule is a 10-hour first shift, Wednesday through Saturday, with working hours from 7:00 AM to 5:30 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:
We are seeking a detail-oriented QA Operations Specialist to support batch record review and lot release activities within a cGMP manufacturing environment. This role is responsible for ensuring the accuracy, completeness, and compliance of production documentation while supporting cross-functional teams to meet quality and operational objectives. The ideal candidate will bring strong technical writing skills, GMP knowledge, and the ability to work independently while contributing to team success and continuous improvement initiatives.
Perform independent review and closure of manufacturing batch records and associated documentation to support product release
Identify and assess discrepancies, non-conformances, and documentation issues, ensuring appropriate resolution in accordance with GMP requirements
Participate in lot release meetings and coordinate documentation readiness to meet release timelines
Apply knowledge of manufacturing processes and quality systems to support investigation and resolution of complex issues
Guide and support junior QA staff on documentation review priorities and decision-making
Ensure all deviations and quality events are appropriately documented, investigated, and closed
Apply data integrity principles in all aspects of work, ensuring compliance with regulatory and company standards
Contribute to continuous improvement initiatives and support daily quality operations as needed
What we are looking for:
Bachelor’s degree in a life sciences discipline or equivalent experience
5–10 years of experience in a cGMP-regulated environment within biotechnology or pharmaceutical manufacturing
Strong understanding of GMP regulations (e.g., ICH, FDA) and good documentation practices
Experience reviewing batch records, lot release documentation, and quality systems processes
Familiarity with systems such as TrackWise, SAP, or similar quality management systems preferred
Strong attention to detail and critical thinking skills, with the ability to identify and resolve issues effectively
Excellent written and verbal communication skills, with the ability to clearly present information and collaborate across teams
Ability to manage multiple priorities, adapt to changing workloads, and escalate issues appropriately when needed
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.