Quality Assurance Rep - Mayagüez

Descripción del Empleo:
Assists in the development, implementation, maintenance and improvement of the quality management system. Assure all work performed is compliant with SOPs and GMP requirements. Assists in laboratory records review, review and update SOP’s, review and approve final analysis reports (COA’s). Responsible for generating and reviewing Certificates of Analysis. Assist in preparation and hosting external audits including customer, ISO and FDA audits. Review ISO standards for revisions and implement changes to ensure compliance. Perform and schedule internal audits. Review and schedule equipment maintenance and calibration certificates. Identify potential corrective actions and track to ensure completion. Temporary Contract.
Requisitos:
Bachelor's Degree in Chemistry. 2-3 years of laboratory experience, preferably in FDA regulated laboratory environment. Data review experience in basic wet chemistry techniques. Problem-solving skills including root cause analysis. Experience in an ISO and/or GMP regulated manufacturing environment. Proficient computer skills specifically MS Office (Word, Excel, PowerPoint). Excellent communication skills. Efficient and effective time management, planning and scheduling skills.