QA Operations Specialist IV - LSA (Nightshift)

Lonza•Portsmouth, NH

2d•Onsite

About The Position

We are seeking an experienced QA Operations Specialist IV 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
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

Nice To Haves

Experience in drug product manufacturing, QA operations, QC, or environmental monitoring within a GMP environment preferred

Responsibilities

Perform the daily rotation through GMP operational areas for the review of GMP documentation and observation of GMP work habits.
Provide direct coaching and feedback for GMP and documentation behaviors.
Conduct GMP training sessions as appropriate to support GMP work-habits and knowledge.
Provide GMP guidance to Manufacturing for routine and non-routine issues.
Is able to independently deal with complex and novel issues.
Respond to QA Hotline calls in support of GMP operations.
Quality Assurance Specialist IV is responsible for decision-making, from simple to complex decisions.
They have the ability to independently assess quality issues and triage the majority of issues but also escalate to Senior management when appropriate.
Authorize placement and removal of Quality Tag Outs.
Participate in Deviation lifecycle, including but not limited to, determination, review of minor deviations and approval of minor deviations
Represent QA in meetings or on project teams, in audits, learning decision making as a QA representative conferring with senior staff and management.
Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures.
Perform other duties as assigned.