QA Specialist II-Raw Materials Compliance

Lonza•Portsmouth, NH

8d•Onsite

About The Position

The QA Specialist II - Raw Materials Compliance is responsible for ensuring the quality, compliance, and availability of raw materials used to support the manufacture of therapies. The role works cross-functionally with Quality, Supply Chain, Logistics, Manufacturing Science & Technology (MSAT), and other stakeholders to maintain uninterrupted operations, address complex quality challenges, and support continuous improvement and inspection readiness. The position is based onsite in Portsmouth, New Hampshire. The specialist performs raw material quality release activities, reviews supplier and manufacturer documentation, and provides guidance on GDP compliance, receipt and disposition activities, inventory controls, and quality documentation. The role also supports investigations and quality events, identifies risks and improvement opportunities, and develops and delivers training on raw material quality requirements.

Requirements

Bachelor's degree required.
Minimum 5 years of quality experience in a regulated industry.
Strong knowledge of cGMP, GDP, and quality system requirements.
Experience reviewing technical documentation, specifications, certificates, and quality records.
Strong attention to detail, organizational skills, and documentation review capabilities.
Proven problem-solving skills, including the ability to identify quality risks and improvement opportunities.
Effective communication, collaboration, and stakeholder management skills in a regulated environment.

Nice To Haves

Science or engineering background preferred.

Responsibilities

Perform quality release activities for raw materials by reviewing documentation, specifications, certificates, and test results.
Review supplier and manufacturer documentation for accuracy, completeness, and compliance with approved requirements.
Provide guidance on GDP compliance, material receipt and disposition activities, inventory controls, and quality documentation practices.
Partner with QA, QC, Supply Chain, Logistics, and MSAT teams to resolve material-related issues and support timely material availability.
Support investigations, deviations, and quality events by providing expertise in raw material quality and compliance requirements.
Identify quality risks and process improvement opportunities and help implement sustainable compliance solutions.
Develop and deliver training and provide support and guidance to cross-functional stakeholders on raw material quality requirements.