Senior Specialist, External Quality Assurance (EQA)

Individual contributor is accountable for ensuring that all Company products managed by EQA are manufactured, packaged, tested, released, stored, and distributed in accordance with Company expectations and all applicable regulatory requirements.

Responsibilities

• Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc) both domestic and foreign.
• Evaluate and release products according to procedure, ensuring that goods are manufactured in conformance with company policies and regulations; review and approve changes to master batch records or laboratory methods/specifications.
• Ensure metrics are compiled, analyzed and reported, identifying trends and root causes to drive process improvements.
• Oversee external entity (EE) sites involved in product release, ensuring they meet company and regulatory standards.
• Act as Qualifi...