Karla M González

Scientist with experience supporting biotechnology, pharmaceutical, and medical device manufacturing operations. Proven exposure with quality systems assurance and investigations, validation & qualification of manufacturing and packaging equipment and processes, validation of laboratory equipment, experience with visual and manual inspection for the aseptic manufacturing and manufacturing technical documentation management such as cleaning instruction records and manufacturing batch records development and/or reviewer. A continuous improvement, self-motivated and results oriented person. Ability to triage multiple priorities. Able to work effectively both independently and as part of a team. Considers the impact on customers before making final decisions. Actively and effectively participate in work teams. Flexible to accept new assignments. Effective communications intra-inter departmentally. Set priorities according to business needs and optimize time usage. Assumes personal responsibility for actions and objectives.