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Portsmouth, New Hampshire, United States
Onsite
QA Operations Specialist II - LSA (Dayshift)
Location: This is a 1st shift position operating on a 12-hour rotating schedule (7:00 AM – 7:00 PM). The schedule follows a rotating pattern of Monday–Tuesday workdays, Wednesday–Thursday off, Friday–Sunday workdays, and continues a biweekly rotation.
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 will you do:
We are seeking an experienced QA Operations Specialist III to provide real-time quality oversight and on-the-floor support for GMP manufacturing operations. This role serves as a key quality presence within operational areas, ensuring compliance, supporting decision-making, and driving high standards of GMP execution. The ideal candidate brings strong technical expertise, sound judgment, and the ability to operate independently while mentoring others.
Provide real-time QA support within GMP manufacturing areas, including on-the-floor presence, observation of operations, and review of GMP work practices
Perform real-time review of batch records (paper and electronic), logbooks, and other GMP documentation to ensure accuracy and compliance
Respond to QA hotline calls, assess quality issues, and make independent, risk-based decisions, escalating as appropriate
Provide guidance to manufacturing routine and non-routine quality issues, including coaching on GMP requirements and documentation practices
Authorize and manage Quality Tag Out activities, including placement and removal in accordance with procedures
Identify, assess, and support resolution of deviations and non-conformances, ensuring appropriate escalation and follow-up
Participate in cross-functional meetings and initiatives, representing QA and contributing to continuous improvement and inspection readiness
What we are looking for:
Bachelor’s degree in life sciences discipline or equivalent experience
2-4 years of experience in a cGMP-regulated pharmaceutical or biotechnology manufacturing environment
Strong understanding of cGMP, ICH guidelines, and quality systems
Working knowledge of manufacturing operations, including upstream/downstream processes, QC, or related functions
Experience with quality systems and tools such as TrackWise, SAP, LIMS, Syncade, and Microsoft Office applications
Ability to independently assess quality issues, make sound decisions, and appropriately escalate complex situations
Strong communication and interpersonal skills, with the ability to provide clear guidance and influence GMP behaviors on the shop floor
Experience in drug product manufacturing, QA operations, QC, or environmental monitoring within a GMP environment 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.
