Supplier Quality Specialist

Flexible & Integrated Technical Services, LLC • Juncos, PR

3d • Remote

About The Position

The Supplier Quality Specialist supports the Quality Systems area of a biopharmaceutical manufacturing operation and owns supplier and raw material change control. The role ensures changes to raw materials and components are assessed, documented, and implemented correctly, and manages supplier-related non-conformances and CAPAs through closure. It is remote, with on-site presence required for audits as needed, and follows an administrative shift as needed.

Requirements

• Bachelor's degree in a science field.
• Four years of experience as a Scientist in the pharmaceutical or regulated industry.
• Bilingual in English and Spanish.
• Project management skills.
• Experience with change control processes, including supplier change notifications and impact assessments of supplier-related quality records.
• Experience with raw materials and components, including specifications and material documentation.
• Experience with TrackWise and SAP.
• Experience authoring non-conformance/CAPA investigations and managing them through closure.

Responsibilities

• Own supplier-related change controls from initiation through closure, ensuring timely and compliant implementation.
• Assess supplier change notifications and quality records for impact on raw materials, processes, and product quality, coordinating with Supplier Quality, Materials Management, Quality Control, and Manufacturing.
• Initiate, revise, and approve manufacturing procedures and raw material documentation affected by supplier changes; serve as a document owner.
• Track and document change control activities in TrackWise and SAP.
• Ensure supplier-related non-conformances are triaged within the established goal.
• Author investigation reports and execute corrective actions.
• Manage non-conformance/CAPA closure within the established goal.
• Monitor and communicate supplier and incident trends.
• Assist in generating training materials related to process and material changes.

What This Job Offers

• Job Type: Full-time