Manufacturing Documentation Reviewer

Descripción del Empleo:
SPECTRAFORCE IS HIRING Manufacturing Documentation Reviewer positions for Manatí, PR. The purpose of this position is to Perform review of procedures, batch record and/or forms to assure update with current practice, audits or cGMP and to address requirements of corrective and prevention actions (CAPAs) among other duties.
Requisitos:
B.S. in Natural Science (Chemistry, Microbiology, Biology) or related fields.
At least 1-2 years of experience in a regulated environment. Manufacturing or Quality experience, preferable in a documentation function.
Computer literate (knowledge on Microsoft Word, Microsoft Excel, Microsoft Power Point, QC-Main and SAP).
Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action. Must be able to correlate events and determine the action plan required to avoid incidents recurrence and apply them.
Knowledge of compendia requirement and cGMP, FDA regulations and the ability to interpret and apply them.
Must possess good verbal and written communication skills in English and Spanish
Capable to manage multiple priorities.
Flexibility to work irregular shifts, overtime and weekends.