Quality Systems Specialist II
About The Position
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. Position details: 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
Requirements
- 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.
- 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
Nice To Haves
- Experience maintaining Quality Systems processes for Veeva, TrackWise, and Compliance Wire experience a plus
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
