Operations Process Support Specialist

Descripción del Empleo:
Responsible for executing manufacturing investigations (QE’s), Corrective Action Preventive Action (CAPA’s),NTR’s, NOE’s, procedures development & revision, and process validation documentation. Acts as facilitator for the necessary information related to the support of the existing processes, the fast tracking for documenting, implementing process modifications and technology for products transfers and validation.
Requisitos:
BS Degree in Science, Pharmacy and/or Engineering. Five (5) years of experience in a Parenteral Manufacturing facility. Strong technical writing and presentation skills. Ability to interpret and analyze statistical data. Knowledge in CGMP’s, OSHA, EPA and other regulatory standards. Excellent communications skills in Spanish /English Provides operational, scientific expertise and compliance knowledge support to the Manufacturing Sterile Operations.