Job Details

  • Title: Global Product Quality Audit Coordinator
  • Code: RCI-0346
  • Location: Princeton, New Jersey 08540 (Temporary Remote)
  • Posted Date: 09/17/2021
  • Duration: 12 Months
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  Job Description

Role Responsibilities

  • Support Global Product Quality – Supplier Quality Team, including Inspections, OPDC Audit Program and Global Audit Program, international conference calls
  • Ensure all required audits (internal and external) are planned and scheduled
  • Monitor adherence to Audit schedule which includes following up with auditors on scheduling and completion of audits
  • Maintain the Internal and External Audit Plans, TrackWise Vendor Management system, ensuring the Approved Supplier List is up to date.
  • Reconciliation of all Internal/External Audit Documentation
  • Administer GMP Supplier Quality mailbox, Team SharePoint site, and GMP Team records (document storage, archiving, retrieval).
  • Support TrackWise Enhancements for Vendor Management and Audit workflows and assist in UAT testing.
  • Support Global Quality Data Studio (GQDS) for Vendor Management and management of OPDC internal and external audits
  • Compile and report key performance indicators, metrics and compliance status of Internal Audits and External audits
  • Monitor qualification status of Qualified Auditors and coordinate with them to maintain their status current with Qualification.
  • Author Standard Operating Procedures, work instructions, forms, templates and other documents
  • Support creation of training and job aids
  • Recognize potential GMP issues and rectifies/escalates, including creation of internal Planned/Unplanned Deviations as needed
  • Independent worker requiring minimal supervision
  • Works collaboratively within Global Product Quality and other functions across Affiliates and Subsidiaries to ensure compliance to internal standards and regulatory requirements
  • Collaborate with cross functional teams and provide guidance in completing ad hoc audit requests.
  • Assist the department in conducting risk assessments per the established audit tools and submit to Manager for review and approval.

Role Requirements

  • BA/BS Degree
  • 6 + Years of experience working within Quality
  • Ability to commute to Princeton, NJ post Covid minimum 5 days per week