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Senior Supplier Quality Systems Engineer

Company: Beacon Hill Staffing Group
Location: Maryland Heights
Posted on: August 6, 2022

Job Description:

Essential Functions

  • Manage the Supplier Quality Program in compliance with applicable regulations by working with suppliers to maintain a compliant status.
  • Conduct supplier audits, evaluations, and assessments
  • Issue supplier complaints and drive for resolution and corrective action.
  • Develop and maintain Supplier Quality Agreements
  • Perform Quality review and approval of Change Controls.
  • Perform statistical evaluations to identify trends and report on Supplier Quality metrics
  • Conduct internal quality audits and develop and assess subsequent corrective action recommendations.
  • Provide support for FDA or other regulatory inspections and customer audits.
  • Provide leadership and coordination on assigned projects.
  • Ensure a safe and quality working environment through training, awareness and compliance to regulatory guidelines and procedures.Requirements
    • Bachelor of Science degree in Life Sciences or Engineering required.
    • Minimum of 5+ years of Quality experience in a finished pharmaceutical manufacturing environment with a strong understanding of and exposure to applicable quality systems.
    • Minimum of 2+ years of experience in Supplier Quality Management and supplier auditing.
    • Minimum of 2+ years of experience in supporting on-site regulatory inspections.
    • Must have working knowledge in Supplier Quality Management, Supplier Auditing, Supplier Assessment, Supplier Quality Agreements, and Corrective Action.
    • Must have a working knowledge of cGMP guidelines and their application in a controlled aseptic environment.
    • Must have strong technical knowledge in pharmaceutical quality systems with proficiency in the following: Stability, Change Control, Internal Auditing, Corrective Action Program, Exceptions, Out of Specification Investigations, Customer Complaints, Regulatory Affairs, Document Management, and Annual Product Reviews.
    • Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation, equipment, processes, and facility systems.
    • Must have a working knowledge of Change Management.
    • Must have experience with statistical tools.
    • Proficient in the use of Microsoft suite of products.

Keywords: Beacon Hill Staffing Group, Springfield , Senior Supplier Quality Systems Engineer, Other , Maryland Heights, Illinois

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