QA Supplier Management Associate

Job Description

POSITION SUMMARY:

This position will support the Quality Assurance department by performing QA activities related to supplier quality management associated with clinical, commercial, and contract product manufacturing. Key responsibilities include reviewing documentation packages for qualifying raw materials and components as well as service providers and completing raw material enrollment activities. Executes and resolves material quality issues through Supplier Corrective Action Report (SCAR) Program with vendor, maintains compliance for site activities associated with local and global Supplier Management, and maintain compliance with regulatory and quality standards.

POSITION RESPONSIBILITIES:

Review of site documentation including but not limited to, risk and technical assessments, vendor related documentation, material qualification packages, and audit reports associated with clinical and commercial processing and ensuring adherence to regulatory agency requirements, standards, policies and values in timely manner.

Collaborates and independently engages with a wide range of co-workers, customers and management within the OpU to gather the input and background knowledge needed to complete assignments

Proactively identifies, takes remedial action, and/or seeks advice when an individual, project, or team goal, deliverable is off schedule

Anticipates issues and elevates them to appropriate management attention immediately.