Bachelor’s Degree in Science or Business Administration Zero (0) to two (2) years of work related. Good oral and written communication skills (English and Spanish) Computer Literate (Microsoft Office) General knowledge of QSR, ISO and FDA regulations and standards Excellent analytical thinking and problem solving skills Good presentation skills Limited use and/or application of technical principles, theories, and concepts Develop solutions to routine technical problem of limited scope. Contributes to the completion of routine technical tasks. Failure to achieve results can normally be overcome without serious effect on schedules and programs. Assures accuracy and completeness of all Bulk, Sterile, and Non-sterile products by receiving and reviewing documentation processed at Pall Life Sciences (PLS), notifying documentation originator when errors and shortage of data are detected, and referring to area Supervisor for correction in a timely manner. Supports operations by preparing Certifications of Compliance for all sterile manufacturing. Prepares Release for shipping all Bulk and Non-sterile products in theSAP System and provides a release form to quarantine area personnel for Sterile products by determining if DHR and sterilization lot reviews have been completed and all release requirements have been met. Support the RGA evaluation and disposition process by providing required copies of DHR. Once disposition is approved, will distribute, process and file the RGA. Complies with customer requirements by assisting to Open Order meetings where shipping priorities of the week are established in coordination with Customer Service and Operations Departments, in addition to assisting the CAPA follow up meetings as required by Documentation Superintendent. Assures quality by avoiding further processing of all products submitted through the Non Conformance System until proper disposition and performs audits to these designated CAPA areas on a regular basis. Assures required documents for product release and additional information required for POR evaluations are received in a timely manner by maintaining effective and continuous communication within all company levels, including external contractors. Complies with internal and external audits by maintaining and providing requested data and documentation during these audits and participating in the processes upon request. Assures completeness and compliance with policies and procedures by reading notes and instructions written on source documents and comparing information with records to detect errors. Maintains updated knowledge of new and current employees by conducting GDP and GMP training. Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing networking links, benchmarking best practices throughout the industry and participating in professional organizations. Contributes to team effort by accomplishing related results as needed Complies with QRS, ISO and all applicable regulations and company procedures. Acknowledge and maintain commitment with the environmental policy, and participate actively in the environmental programs to achieve the objectives and targets with their area. Participate in the development of environmental improvement projects, which imply the minimization, all possible negative environmental impacts of daily operations and activities.
