Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
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.
Key Responsibilities
ComplianceWire Administration
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Serve as the site system administrator for ComplianceWire for the cGMP site and other assigned sites, as needed.
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Support EHS and other site administrators as needed and coordinate with Global support for escalated issues.
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Manage administrative paperwork, create new user groups, develop new curricula, and assign training requirements.
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Engage ComplianceWire Business Support for tasks that cannot be completed internally, including COE curriculum-related needs.
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Deliver the Training Administration workshop for the AbbVie network twice per year to maintain internal access and support ongoing system administration responsibilities.
Training Compliance Reporting
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Generate reports for website use, inspection readiness, and ad hoc requests as needed.
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Monitor auto-assigned user groups on a daily basis.
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Review and log new hires and terminations weekly.
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Monitor form submissions requiring action, including Trainer Qualification Forms and Trainer Requalification submissions.
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Monitor service provider account forms to create or close accounts as needed.
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Create and terminate service provider user accounts using Training Admin user edit functions.
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Generate weekly, monthly, quarterly, and year-to-date Tier 3 metrics for on-time training compliance, including both overall and GMP-only training metrics.
General ComplianceWire Support
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Complete data entry, assignment, and reporting requests submitted through the Quality Planning queue.
QA and KMT Website Maintenance
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Update the QA and KMT internal websites at least weekly.
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Maintain the QA internal website and preserve its current path due to active training materials linked to the site.
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Support the Training Website in SharePoint in coordination with other authorized users.
Training Materials Management
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Manage all training materials and approvals in Veeva OneVault.
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Create quizzes and eForms in the LMS.
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Develop computer-based training modules and quizzes using Articulate, including SCORM content.
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Create and monitor user groups using established membership criteria.
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Generate required forms and complete assignment of new training requirements, with knowledge of ABC user groups and curricula.
Annual Area Access Audit Support
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Support the annual Area Access Audit/G-023 process, typically conducted in June.
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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.
Qualifications
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Bachelor’s degree required in a scientific discipline or equivalent experience.
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5+ years of combined experience in Manufacturing, QA, R&D in pharmaceutical, biologics, device or chemical industry
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Experience in quality systems administration, training compliance, or a related regulated environment.
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Working knowledge of ComplianceWire, LMS platforms, and training assignment processes.
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Strong organizational, documentation, and reporting skills.
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Ability to manage multiple priorities and respond to time-sensitive requests.
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Proficiency with website maintenance, training content tools, and compliance-related administrative systems.
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Attention to detail and strong communication skills.
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Preferred Attributes
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.
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Ability to collaborate effectively across sites, functions, and levels of the organization.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role atthe time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors includinggeographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested,and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to aparticular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion,consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
