Senior, Quality Associate I

AbbVie•Worcester, MA

About The Position

The Senior Quality Associate I is responsible for supporting quality system administration, training compliance, website maintenance, training content development, and audit readiness activities. This role serves as a key administrator for ComplianceWire electronic learning management system (LMS) and associated training systems, ensuring accurate assignment, tracking, reporting, and maintenance of training requirements across assigned sites. The position also supports the development and management of training materials, user groups, service provider accounts, and annual access audit activities.

Requirements

Bachelor’s degree required in a scientific discipline or equivalent experience.
5+ years of combined experience in Manufacturing, QA, R&D in pharmaceutical, biologics, device or chemical industry
Experience in quality systems administration, training compliance, or a related regulated environment.
Working knowledge of ComplianceWire, LMS platforms, and training assignment processes.
Strong organizational, documentation, and reporting skills.
Ability to manage multiple priorities and respond to time-sensitive requests.
Proficiency with website maintenance, training content tools, and compliance-related administrative systems.
Attention to detail and strong communication skills.

Nice To Haves

Experience supporting audit readiness and regulated training environments.
Familiarity with administration of electronic learning management systems, Veeva OneVault, SharePoint, Articulate, and SCORM-based training development.
Ability to collaborate effectively across sites, functions, and levels of the organization.

Responsibilities

Serve as the site system administrator for ComplianceWire for the cGMP site and other assigned sites, as needed.
Support EHS and other site administrators as needed and coordinate with Global support for escalated issues.
Manage administrative paperwork, create new user groups, develop new curricula, and assign training requirements.
Engage ComplianceWire Business Support for tasks that cannot be completed internally, including COE curriculum-related needs.
Deliver the Training Administration workshop for the AbbVie network twice per year to maintain internal access and support ongoing system administration responsibilities.
Generate reports for website use, inspection readiness, and ad hoc requests as needed.
Monitor auto-assigned user groups on a daily basis.
Review and log new hires and terminations weekly.
Monitor form submissions requiring action, including Trainer Qualification Forms and Trainer Requalification submissions.
Monitor service provider account forms to create or close accounts as needed.
Create and terminate service provider user accounts using Training Admin user edit functions.
Generate weekly, monthly, quarterly, and year-to-date Tier 3 metrics for on-time training compliance, including both overall and GMP-only training metrics.
Complete data entry, assignment, and reporting requests submitted through the Quality Planning queue.
Update the QA and KMT internal websites at least weekly.
Maintain the QA internal website and preserve its current path due to active training materials linked to the site.
Support the Training Website in SharePoint in coordination with other authorized users.
Manage all training materials and approvals in Veeva OneVault.
Create quizzes and eForms in the LMS.
Develop computer-based training modules and quizzes using Articulate, including SCORM content.
Create and monitor user groups using established membership criteria.
Generate required forms and complete assignment of new training requirements, with knowledge of ABC user groups and curricula.
Support the annual Area Access Audit/G-023 process, typically conducted in June.
Validate and verify that all individuals with access to areas have the required training assigned and completed for each area identified in the G-023-F01 form.