QA Specialist II-Records

Lonza • Portsmouth, NH

2d • Onsite

About The Position

The QA Specialist II – Records serves as a subject matter expert (SME) in records center operations, with a strong understanding of good documentation and records management practices. This role ensures compliance with regulatory requirements and company policies while supporting record-related processes across the organization. The specialist leverages advanced problem-solving skills to manage complex requests, improve systems, and ensure the integrity, accuracy, and timely availability of records.

Requirements

• Associate’s degree in a technical or business-related field
• Minimum of 2 years of experience in a cGMP-regulated environment (0–4 years overall experience)
• Experience managing archived records, including tracking, retrieval, and delivery processes
• Proficiency in electronic document management systems and validation of scanned records
• Strong understanding of records classification and records management practices
• Excellent organizational skills, attention to detail, and ability to manage multiple priorities
• Ability to work independently while providing guidance and oversight to others
• Strong verbal and written communication skills
• High level of accuracy in data entry and documentation
• Self-motivated with the ability to perform in a fast-paced, time-sensitive environment
• Customer-focused mindset with strong service orientation
• Advanced proficiency in Microsoft Office applications

Responsibilities

• Maintain control of archived records by coordinating tracking systems and ensuring timely retrieval and delivery of both paper and electronic records
• Process and resolve complex records retrieval requests, including legacy and minimally identified records
• Provide high-level support for audits by ensuring records are available, accurate, and audit-ready
• Manage relationships with third-party storage vendors, including contracts, issue resolution, and coordination of services
• Determine and prioritize daily operations of the Records Center to meet business objectives and timelines
• Lead or support system improvements, upgrades, and documentation initiatives within Records and Information Management
• Oversee logbook issuance processes, including creation, tracking, staging, replenishment, and business continuity management
• Ensure secure and timely transport of records to and from the Records Center
• Support batch record scanning processes, ensuring accurate archiving and upload to appropriate systems or customer portals
• Apply data integrity principles in all activities in compliance with Lonza policies and procedures
• Collaborate cross-functionally and represent Records and Information Management in meetings and projects
• Perform additional duties as assigned

Benefits

• Performance-related bonus
• Medical, dental and vision insurance
• 401(k) matching plan
• Life insurance, as well as short-term and long-term disability insurance
• Employee assistance programs
• Paid time off (PTO)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree