QA Specialist III-Operations
LonzaPortsmouth, New Hampshire, United States
Posted April 25, 2026
Full Time
About the Company
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.
Job Description
The QA Specialist III operates with a high degree of autonomy while partnering closely with GMP operators and manufacturing teams to provide real-time, on-the-floor Quality Assurance support for operational areas involved in GMP activities.
Requirements
- Bachelor’s degree in a scientific or engineering discipline (e.g., Chemistry, Biology, Biochemistry, Chemical Engineering, or related field) required.
- Solid understanding of cGMP regulations and ICH guidelines.
- Working knowledge of critical manufacturing process steps and parameters (e.g., Fermentation, Purification, Quality Control).
- Understanding of product clearance requirements during process changeovers.
- Familiarity with deviation management processes and documentation practices.
- Experience with quality and manufacturing systems such as TrackWise, SAP, LIMS, Syncade, and Microsoft Office.
- Ability to identify compliance risks and escalate issues appropriately.
- Strong situational awareness to recognize abnormal or potentially impactful events and escalate to the appropriate stakeholders.
Benefits
- 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)