Supplier QA Analyst

3 weeks ago

Libertyville, United States Advanced Clinical Full time

Supplier QA Analyst


Onsite Role

12+ month contract

**Please no C2C or 3rd party candidates


**Candidates should have some experience in FDA-regulated environments (Pharmaceutical, Med Device, Biotech, etc.). 2-5 years of experience ideal


What You’ll Work On

  • Supports Supplier Quality activities and strategy for specific Supplier evaluations and resolution planning (e.g. SCARs) per established policies and procedures.
  • Provides guidance of Supplier Quality process to organization and stakeholders. Acts as a liaison and IT SME to ensure successful evaluation and monitoring of Suppliers.
  • Identifies and assembles Stakeholders with all needed parties/expertise to effectively and efficiently address assigned Supplier evaluations.
  • Exercises critical thinking to ask questions of discovery, confirm the veracity of answers, and locate information for Supplier quality record completion.
  • Exercises Project management skills to drive for completion of Supplier quality activities (assignment of action ownership, details, milestone dates) according to schedule. Hold CFT members accountable for deliverables and create a sense of ownership and momentum to drive results.
  • Monitor due dates for supplier questionnaires and associated control plans; works with IT owners to ensure implementations are completed on time.
  • Escalates issues (due dates and compliance items) to senior leadership.
  • Accountable for maintaining, reporting, and evolving the Supplier quality metric data for, including developing management review metrics for upper management communications as needed.
  • Escalates status, implementation, and effectiveness issues to Supplier quality management to communicate regular progress and mitigate quality system risk as needed.


The primary activities include:

  • Reviewing and approval of risk questionnaires received from vendors using quality tool(s)
  • Providing input on the vendor’s overall risk rating
  • Population and completion of Supplier files in the quality repository
  • Identifying quality-related gaps
  • Providing support to the CAPA team through the implementation of actions
  • Providing general quality support

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