DUTIES :
- Support SQM team and core SQM processes with onboarding of new suppliers and materials;
- Assign, track and reconcile GMP documentation;
- Support Quality activities for key processes including Vendor / Supplier Change Notifications (VCN / SCNs) and Supplier Corrective Action Requests (SCARs);
- Establish and implement Quality Technical Agreements with suppliers;
- Construct internal and external audits as well as regulatory inspections;
Support supplier status changes as required to ensure that the Approved Supplier (Vendor) List is accurate and complete; and
Maintain filing system for the supplier quality documentation.
TRAVEL : Up to 10% domestic travel required.
REQUIREMENTS :
Master’s degree or foreign degree equivalent in Mechanical Engineering, Industrial Engineering, or a related field of study plus 0 years of experience.
Employer will also accept a Bachelor’s degree or foreign degree equivalent in Mechanical Engineering, Industrial Engineering, or a related field of study plus 2 years of manufacturing quality assurance experience or related experience as an equivalent alternative.
Required knowledge or experience with :
- 1. GMP Regulations;
- 2. Quality Assurance;
- 3. Change Controls;
- 4. QMS Auditing;
- 5. CAPA;
- 6. Quality System regulations;
- 7. Supplier and Material Risk estimation;
8. Microsoft Office; - MS Excel, MS Word and MS PowerPoint
9. Adobe Software Suites; - Adobe Acrobat, Adobe Sign
10. Smartsheet WorkApps
- 11. Leading Cross-functional meetings;
- 12. Triage of Supplier / Vendor Notifications;
13. Data Analysis; and
14. Technical Writing.
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