SpringfieldILRecruiter Since 2001
the smart solution for Springfield jobs

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Log In or Create An Account

Get the latest Illinois jobs by following @recnetIL on Twitter!

Springfield RSS job feeds