QA Specialist II-Records

About the role

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.

Responsibilities

• Leverage 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.

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.

Qualifications

None specified.

Skills

None specified.

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).

Pay

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

Schedule

The typical work schedule is Monday through Friday, 8:00 AM–5:00 PM EST.