Scope of Function:
The Manager, Quality Assurance Supply Chain Auditor, is responsible for ensuring that all suppliers engaged by GBI are appropriately evaluated and dispositioned to provide materials, consumables and equipment based on their impact on product quality. In addition, the Manager, Quality Assurance Supply Chain Auditor is responsible for Supplier on site audits, maintenance of the Approved Supplier List (AVL) and maintenance of the Approved Materials List (AML).
Reports to: AVP Quality & Regulatory (or Designated Alternate).
Specific Duties:
- Manage and maintain current Supplier Qualification SOPs, the Approved Supplier List (AVL) and the Approved Material List (AML) within Master Control.
- Manage and maintain the current Approved Suppliers, and Approved Materials within NetSuite.
- At the beginning of each calendar year prepare a schedule for Supplier audits and share with Process Development, MSAT, Quality Control, Manufacturing & Quality Assurance.
- Coordinate Supplier audits and material approvals with Process Development, MSAT, Quality Control, Manufacturing & Quality Assurance.
- Coordinate Supplier audits and material approvals with materials management.
- Use a risk assessment process to determine the impact of a supplier on product quality and consequently if a supplier audit is required, and if required if the audit should be an onsite audit or a desk audit.
- Prior to each onsite audit, prepare a scope for the audit and use a risk assessment process to determine the focus of the audit.
- Prior to each desk audit, prepare a scope for the audit and use a risk assessment process to determine the focus of the audit.
- Prepare an audit report immediately after each onsite audit, listing observations and based on the observations disposition the Supplier as approved (subject to addressing certain observations) or, conditionally approved (subject to addressing certain observations), or not approved.
- Prepare an audit report after each desk audit, listing observations and based on the observations disposition the Supplier as approved (subject to addressing certain observations) or, conditionally approved (subject to addressing certain observations), or not approved.
- Maintain the AVL and the AML in accordance with Supplier qualification activities.
- Prepare Supplier Quality Agreements and submit to the AVP of Quality and Regulatory for approval.
- Maintain the Supplier Quality Agreements in Master Control.
- Maintain Supplier audit files in Master Control.
- Prepare, implement and revise Supplier Qualification SOPs, the Approved Supplier List SOPs and the Approved Material List SOPs.
- Prepare, implement and revise Supplier Qualification, Approved Supplier List and Approved Material List FORMs.
- Assist with investigations associated with Supplier Qualification, approved Suppliers and Approved Materials.
- Other duties as assigned.
Education and Experience:
- Bachelor’s degree preferred, Associate Degree or appropriate experience.
- Minimum 5 years of Supplier Audit experience.
- Proficient in Microsoft Office products.
- Must be willing to travel and work on the weekends, as needed.
Interacts with: Interact with all departments, and outside contractors.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice.
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