QA Specialist - Supplier Quality

Position: QA Specialist I - Supplier Quality
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
** We are PCI.
** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. This position is part of PCI's Quality Compliance team responsible for the quality aspects of supplier quality management for suppliers that provide raw materials, components, contract test labs and services for GMP operations.

The position is responsible for ensuring all aspects of the Supplier Qualification program are successfully executed across all PCI facilities.

Essential Duties and Responsibilities:

+ Responsible for follow up and tracking of supplier audit observations to ensure timely closure. + Monitor and communicate supplier change notifications and manage supplier non-conformance and complaint handling. + Responsible for reviewing all audit responses to assure non-recurrence of deficiencies. + Drafting, review and management of supplier quality assurance agreements (QAA's) and non-disclosure agreements. + Collaborate with Corporate Supplier Quality team members;

align on Supplier Qualification program. initiatives, report status of site-specific Supplier Qualification actions. + Support Supplier Risk Assessments. + Support Annual Product Quality Review's. + Support Quality System events impacting the Supplier Quality program. + Request, reconcile, and file Supplier Qualification documentation. + Provide support for Quality Council meetings. + Writes and revises Standard Operating Procedures (SOP). + Support continuous improvement initiatives.

+ Performs other duties as assigned. Special Demands: + Is assigned tasks and duties regularly from direct manager and senior team members. + Ability to maintain organization of assigned tasks and meet deadlines. + Ability to think strategically and tactically. + Frequent reading, writing, and verbal communication. + Able to work in a highly complex and regulated environment. + Able to translate ideas to actual concepts and processes.

Work Environment: + Interacts with all departmental staff, external clients and suppliers + _TRAVEL -