Quality Line Auditor - Part Time/Weekend

Descripción del Empleo:
The individual will provide quality consult during manufacturing activities. Performs the review of current manufacturing records, processes and practices. The incumbent must be familiar with the different manufacturing processes. Shall be able to detect any anomalous incident during these activities.
-Understand plant GMP and safety regulations.
-Approval of the room cleaning prior to start the manufacturing process.
-Perform review of assorted documentation during manufacturing activities.
-Audit the manufacturing areas and activities to ensure compliance.
-Performed Tighten AQL’s and finished product AQL’s as required.
-Notify Manufacturing and QA Supervisors when an incident or any problem in the areas has been observed as applicable.
-Perform any new assignment
Requisitos:
Education: Bachelor degree in Biology or related Sciences

Training:
Above average knowledge of FDA Regulations. Familiar with activities related to QA, Manufacturing.

Previous experience:
Three years of experience working in a pharmaceutical environment. At least two years working in QA areas.

Incumbent must be fully bilingual in both English and Spanish, with a strong, thorough, and concise written and verbal communications skills and above average computer literacy (MS-Office).