Senior Specialist, Quality Assurance (Hybrid)

**Job Description**

**Job Description:**

The Rahway based **Senior Specialist, Global Development Quality Operations – API** , is responsible for independent approval of documentation to support Good Manufacturing Practice (GMP) clinical supply API manufacture, testing, release, and maintenance in support of our company's clinical supply programs. This person will also independently approve documentation accompanying the disposition of API materials to ensure conformance to appropriate regulatory and company requirements. In support of clinical supply manufacture and/or inspections independently perform or coordinate routine and specialized audits of audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities to ensure compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and other applicable worldwide regulations and our Company's requirements.

**Primary responsibilities include ...