QA Specialist II - Operations

Lonza•Portsmouth, NH

1d•Onsite

About The Position

The QA Specialist II – Operations provides real-time, on-the-floor Quality Assurance support in GMP operational areas, partnering closely with GMP operators and manufacturing teams. The role supports compliance by promoting adherence to GMP standards, data integrity principles, and internal quality procedures. It handles operational compliance questions and assignments, supports inspection readiness, and may guide or coach less experienced staff. The job is based in Lonza’s Portsmouth, New Hampshire office and works a 12-hour third-shift rotating schedule from 7:00 PM to 7:00 AM. The schedule rotates between Monday–Tuesday workdays, Wednesday–Thursday off, and Friday–Sunday workdays on a biweekly rotation.

Requirements

Basic understanding of cGMP regulations and good documentation practices.
Familiarity with manufacturing process steps and quality control activities within a regulated environment.
Awareness of product clearance and line clearance requirements during manufacturing operations.
Experience following standard operating procedures (SOPs) and accurately completing required documentation.
Ability to recognize potential compliance issues and communicate concerns to supervisors or appropriate team members.
Strong attention to detail and ability to identify unusual events or conditions and escalate appropriately.
Effective communication and organizational skills, with the ability to work collaboratively in a team environment.
Ability to prioritize routine tasks and work effectively under general supervision.

Nice To Haves

Associate or bachelor's degree in a scientific or engineering discipline, such as Chemistry, Biology, Biochemistry, Chemical Engineering, or a related field; equivalent relevant experience may be considered.
Familiarity with manufacturing and quality systems such as SAP, LIMS, TrackWise, Syncade, or similar systems.

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 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 support operational GMP-related questions or events.
Make routine GMP-related decisions independently 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 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 inspection readiness through proactive QA oversight and engagement.
Perform additional duties as assigned.