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Supplier Quality Engineer

00000, IL 00000

Posted: 01/30/2023 Employment Type: Contract Job Category: Other Job Number: 542954 Is job remote?: No Country: United States

Job Description


Target PR Range: 60-70/hr
*Depending on exp

 

Client is searching for a Supplier Quality Engineer resource for a 12-month, remote project.

 

The Supplier Quality Engineer, within the Quality and Compliance Team, will report to the Associate Director, Supplier and Clinical Quality. The Supplier Quality Engineer will provide overall support for the Quality supplier management process.
  • Help to develop and maintain the compliance framework for supplier qualification and CDMO product / intermediate disposition activities.
  • Work within the Quality Team to ensure compliance with GLP/GCP/GMP, ICH, FDA and other regulatory agency guidance and requirements, as well as supplier and internal company quality systems requirements.
  • Act as the lead Supplier Quality Engineer working to help the current Supplier Quality Associate to develop their SQS within the EQMS and paper quality system.
  • Help to build the supplier business system process to current best practice standards.
  • Prepare, track, complete and maintain supplier Quality documents and records (e.g., questionnaire, audit plans/agendas and reports, Quality Agreements, approved supplier list, risk assessments, deviations, CAPAs, change controls, etc.) to ensure compliance to internal and external requirements.
  • Plan, lead and perform various types of audits (e.g., onsite, remote, qualification, quality system, product- or process-based, for cause audits) on GxP service, material, manufacturing, testing, clinical and nonclinical supplier sites.
  • Develop and create audit agendas and reports, coordinate action plans and follow-up activities with auditees to ensure proper completion.
  • Ensure Quality Agreements, and other technical and legal documents with suppliers are clear, comprehensive and followed.
  • Investigate, triage and document supplier quality issues/deviations, and recommend corrective actions / CAPAs related to supplier issues, elevating critical quality issues to Quality Management.
  • Assess supplier / vendor change notifications for impact to qualification status and internal documentation, consulting with internal teams as applicable to ensure proper actions are determined and completed.
  • Review and approval of supplier documents and records, including batch records, protocols, testing records, specifications and reports.
  • Perform internal approval and / or disposition activities for CDMOs and CROs, including review of batch records and testing records, review and closure of non-conformances, change controls and CAPAs.
  • Work closely with internal teams, as well as CDMOs, CROs, testing sites and depots to provide QA oversight and assess compliance with regulations, protocols and other established processes to ensure objectives are met in a complete and timely manner.
  • Prepare and report on supplier quality metrics as required.
  • Participate in internal, clinical, non-clinical, regulatory and partner audits as required.
  • Assist in training new staff in quality system requirements and applicable regulations.
  • Mentor and/or train junior staff in Supplier Quality processes and tasks.
  • Assist the Quality and Compliance Team with other projects and tasks, where applicable.
  • Support an environment of continuous improvement with an emphasis on relationship management, shared accountability and open communication.

 

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
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