Quality Systems Specialist II

4 weeks ago

Waltham, United States Alkermes, Inc. Full time

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.

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

ACADEMIC/TECHNICAL QUALIFICATIONS:

  • 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
  • or Associate's degree with 8-10 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, TrackWise, 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

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PDN-9c17c2f3-76c8-43b4-8a44-f786d0f42fa4

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