Work Schedule

Standard (Mon-Fri)



Environmental Conditions

Office



Job Description




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.