QA Operations Specialist III - LSA

Lonza•Portsmouth, NH

1d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in life sciences discipline or equivalent experience
5–8 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

Responsibilities

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
Serve as a resource and mentor to junior QA staff, providing coaching, training, and support in GMP decision-making
Participate in cross-functional meetings and initiatives, representing QA and contributing to continuous improvement and inspection readiness