Quality Systems Specialist II

Quality Systems Specialist II KEY AREAS OF JOB ACCOUNTABILITY

The Quality System Specialist II, under the direction of the QS&C management team, will be responsible to support and continuously improve the global DMS, LMS & QMS systems, and their operations, as assigned, to ensure that they are compliant and fit for intended use in accordance with applicable global SOPs.

• Collaborate with global, site and departmental subject matter experts and site process leads as appropriate to support governance of DMS/LMS/QMS applications, including harmonization of processes across sites
• Assist in gathering requirements for improvements and ongoing maintenance by participating in meeting/workshops with Site Process Owners and business SME. Participate and sometimes lead user forums or working team meetings to gather ongoing requirements and prioritize and triage issues
• Provide project and report statuses to manager/ working teams as needed
• Provide guidance to Subject Matter Experts and Site Process Leads on system functionality as well as supporting quality system processes
• Support the development and design of evolving or future Quality Systems
• Initiate and manage change controls, with associated documentation requirements, to completion
• Ensure system is maintained in a validated state by participating, and when appropriate leading, periodic user access review, ongoing change management, business administration, and deviations/CAPAs associated with DMS/LMS/QMS
• Support and when appropriate lead investigation, escalation, and resolution of issues identified on the system including initiation and owning of related deviations, CAPAs and Change Controls as needed
• Support validation activities as requested; this includes but is not limited to authoring/execution/ facilitation of UAT/regression testing associated with system upgrades/ project implementation
• Support manager with ongoing communication from vendor/IT where required
• Communicate milestones and planned changes to the user community; promote use of DMS/LMS/QMS
• Provide customer support through system and training management and onboarding of new users
• Support Quality System Vendor Audits as a Business SME, as needed
• Generate metrics to support quality systems
• Support regular system updates/ releases and provide assessment of and recommendations regarding new features
• Author and maintain key user-related documentation and ensure it is kept up to date as new functionalities are enabled, created and/or modified

• Bachelor’s degree or higher in relevant computer/technical/quality/scientific discipline, preferably multi-disciplinary with a strong technical and quality background
• Minimum of 3-6 years of experience in a high volume commercial / clinical pharma / healthcare facility
• Proficient in MS Word, Excel, and Quality System processes. Experience maintaining Quality Systems processes for Veeva, Track Wise, and Compliance Wire experience a plus
• Understanding and working knowledge of US FDA and European regulatory requirements and GAMP, and the ability to determine phase appropriate requirements
• Knowledge of Regulatory Compliance and ICH Guidelines