Work Schedule

Environmental Conditions

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.