QA Specialist II-Lot Release

Lonza•Portsmouth, NH

1d•$62,000 - $98,000•Onsite

About The Position

The QA Specialist II – Lot Release plays a critical role in ensuring the timely and compliant release of production batches at our Portsmouth, NH facility. This position is responsible for the independent review, coordination, and completion of all documentation required for batch disposition, working closely with cross-functional teams to meet internal and external quality and regulatory expectations. The role also provides guidance and mentorship to junior QA staff, supports continuous improvement initiatives, and serves as a subject matter expert for batch release activities.

Requirements

Demonstrated hands-on experience in Quality Assurance within a regulated manufacturing environment, with direct involvement in batch record review, product disposition, and GMP-compliant documentation.
A combination of education and years of experience will be considered.
Proficiency with Microsoft Office tools (Word, Excel, Outlook); experience with SAP and TrackWise preferred.
Working knowledge of cGMP regulations and guidelines (e.g., ICH Q7, 21 CFR Parts 210/211, 820).
Strong attention to detail, critical thinking, and problem-solving skills.
Demonstrated ability to identify nonconformances, assess risk, and escalate issues appropriately with or without guidance.
Motivated self-starter with the ability to adapt to changing priorities and manage multiple deliverables.
Ability to work effectively both independently and within a team environment.
Clear and logical communication skills with the ability to present facts, understand differing perspectives, and collaborate across functions.

Nice To Haves

Experience supporting batch release, product disposition, labeling systems, and regulatory or customer audits preferred.

Responsibilities

Independently review and close batch disposition checklists and all supporting documentation required for production batch release.
Collect, compile, and review executed batch documentation in accordance with approved procedures, product specifications, and batch disposition checklists.
Review executed batch records, QC release assays, controlled testing (internal and contracted), and customer-controlled testing to ensure compliance with specifications.
Prepare and compile complete batch release packages, including Certificates of Analysis (CoA) and final product labels.
Create, revise, and maintain product specifications, act as document owner for specification changes as applicable.
Facilitate daily batch release meetings with cross-functional stakeholders using visual management systems; maintain site-wide batch release schedules and metrics.
Interact with Manufacturing, Quality Control, Supply Chain, and other stakeholders to obtain batch release deliverables in a timely manner.
Complete SAP movements and support daily management systems.
Support final product shipment activities, including labeling, shipping documentation, and transmission of batch documentation to customers per Quality Agreements.
Maintain the site GMP label system, including master label books, label creation, user access control, and quarterly audits of label software users.
Identify, assess, and investigate nonconformances (simple and complex), understand GMP implications, and determine appropriate actions with minimal management guidance.
Apply Data Integrity principles in all aspects of work in compliance with company policies and procedures.
Train, coach, and mentor junior QA Specialists; guide release priorities and support decision-making.
Lead or participate in process improvement initiatives and cross-functional projects.
Interact with regulatory inspectors, customer auditors, and internal auditors as a batch release subject matter expert.
Perform other duties as assigned.