Product Release Associate II
NovenMiami, Florida, United States
Posted February 5, 2024
Full Time
About the Company
Noven Pharmaceuticals is a specialty pharmaceutical company dedicated to research, development, manufacturing, and marketing of prescription drugs. Focused on transdermal drug delivery, Noven develops innovative products that enhance patient care. With state-of-the-art facilities in Miami and a commitment to women's health, the company aims to significantly benefit patients while advancing pharmaceutical innovation.
Job Description
The Product Release Associate II reviews batch records, analytical results, and other GMP documentation for accuracy and completeness. They ensure compliance with FDA and cGMP regulatory requirements and assist with product complaint investigations and internal projects.
Requirements
- BS degree or technical equivalent
- Three to five years of professional experience in pharmaceutical industry and Product Release
- PC literate with basic knowledge of application software
- Understanding of internal SOPs, FDA guidelines (CFRs), and cGMP regulations
- Experience with MES e-Batch Record system, JDE ERP system and TrackWise is a plus