Experience in Quality/Packaging. Review and approve manufacturing procedures. Approve process validation protocols and reports related to manufacturing. Lead investigations of complex scenarios. Lead site audits and validation protocols and summary reports review/approval. Own site quality program procedures. Review Risk Assessments. Request Quality on incident triage team. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment. Experience in Trackwise is desired. Experience with incoming QA and GMP. Fully Bilingual in Spanish and English.
Must have a Bachelor’s Degree in Life Sciences or Engineering or equivalent combination of education and/or experience. Must have 5 years or more of experience related to quality assurance of parenteral products in the pharmaceutical industry. Strong organizational skills, including ability to follow assignments through to completion. Initiate and lead cross functional teams. Enhanced skills in leading, influencing and negotiating.