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Portsmouth, New Hampshire, United States
Onsite
QA Specialist II – Records
Location: This position is based in our Portsmouth, NH office. The typical work schedule is Monday through Friday, 8:00 AM–5:00 PM EST.
What you will get:
Below you will find a comprehensive summary of the benefits package we offer:
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).
Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.
What will you do:
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.
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
What we are looking for:
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
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.