Massachusetts Jobs

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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.