QA Specialist III-Operations

Lonza•Portsmouth, NH

2d•Onsite

About The Position

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. This role is responsible for supporting compliance within manufacturing operations by ensuring adherence to GMP standards, data integrity principles, and internal quality procedures. As an experienced member of the QA team, the QA Specialist III handles complex and time-sensitive assignments, supports inspection readiness, and may provide guidance or coaching to less experienced staff. The position serves as a key Quality representative within operational areas, helping to maintain compliant processes, documentation practices, and overall operational excellence.

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.

Responsibilities

Conduct daily QA presence in GMP operational areas to review documentation and observe GMP practices.
Partner with Manufacturing and Operations teams to ensure compliance with GMP standards and internal procedures.
Provide guidance and coaching on GMP behaviors and documentation practices in collaboration with Manufacturing leadership.
Support Manufacturing teams with both routine and non-routine GMP compliance questions or issues.
Escalate complex compliance issues or risks to senior QA staff or management when appropriate.
Respond to QA Hotline calls and provide support for operational GMP-related questions or events.
Independently make routine GMP-related decisions and collaborate with senior staff or management on more complex decisions.
Support equipment status management, including authorizing placement or removal of Quality Tag Outs and releasing equipment from product changeover.
Apply Data Integrity (DI) principles in all aspects of work in accordance with company policies, guidelines, and procedures.
Represent Quality Assurance in meetings and cross-functional project teams, contributing to compliance-focused decision making.
Support the facility’s state of inspection readiness through proactive QA oversight and engagement.
Perform additional duties as assigned.