Noven Pharmaceuticals, Inc - Miami, FL
Product Release Associate II - TEMP (Biotech)
The purpose of this position is the review of executed batch records, analytical results and other GMP documentation for accuracy, completeness and conformance to established documentation standards, including disposition of starting materials, in process and finished products. This position assures that all specifications are met at each stage of manufacturing and prior to final product release to comply with FDA and cGMP regulatory requirements. The scope of support includes review of batch records and analytical results for product complaint investigations and Product Development activities, and serves on assigned internal projects as a technical/compliance resource to solve quality issues.
Competencies:
Education / Experience:
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.
Judgment / Decision Making:
Duties are performed under general direction within a framework of established and routine guidelines; some modification and interpretation required.
Work Environment:
Air-conditioned office environment.
Physical Demands:
Visual acuity and manual dexterity required to review documents and operate computer.