QA Specialist III-Operations

Lonza•Portsmouth, NH

15h•Onsite

About The Position

We are seeking a detail-oriented QA Specialist III, Operations to support document review and quality oversight activities within a cGMP manufacturing environment. This role is responsible for reviewing and approving GMP documentation, ensuring compliance with internal procedures and regulatory requirements, and supporting cross-functional teams to maintain high-quality standards. The ideal candidate will bring strong technical writing and review experience, a solid understanding of quality systems, and the ability to work independently while collaborating effectively across the organization.

Requirements

Bachelor’s degree in scientific discipline or equivalent experience
4-6 years of experience in a pharmaceutical, biotechnology, or cGMP-regulated environment
Strong experience reviewing and approving GMP documentation across operations, validation, engineering, or quality functions
Solid understanding of cGMP regulations, documentation practices, and quality systems
Strong attention to detail and analytical skills, with the ability to identify and resolve documentation and compliance issues
Effective written and verbal communication skills, with the ability to collaborate across cross-functional teams
Ability to manage multiple priorities and work independently while meeting deadlines
Customer-focused mindset with the ability to provide clear guidance and escalate issues as appropriate

Responsibilities

Independently review and approve GMP documentation, including SOPs, work instructions, forms, and electronic batch records within the document management system
Review and approve validation and qualification documentation, including protocols and summary reports for equipment, instrumentation, and computer systems
Review non-DMS documentation such as maintenance records, engineering documentation, and supporting quality records to ensure compliance
Provide detailed feedback and recommendations during document review to ensure accuracy, completeness, and adherence to procedures
Ensure document changes are appropriately justified, documented, and aligned with revision control processes
Serve as a subject matter resource for document review related to validation, equipment, and analytical systems
Collaborate with QA, Manufacturing, Engineering, and other stakeholders to resolve documentation and quality issues
Support continuous improvement efforts to enhance documentation practices, compliance, and overall quality systems