Job Opportunities API

Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico. Administrative Shift Job Description: Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and quality assurance activities . Requirements & Qualifications: • Experience in Quality and Compliance, regulatory audits, validation, characterization, automation validation reports. • Review and approve deviations, critical utilities and environmental monitoring trend reports. Functions: • Review and approve product MPs. • Approve process validation protocols and reports for manufacturing processes. • Request Quality on incident triage team. • Approve Environmental Characterization reports. • Release of sanitary utility systems. • Approve planned incidents. • Represent QA on NPI team. • Perform investigations and audits. • Own site quality program procedures. • Designee for QA manager on local CCRB. • Review Risk Assessments. • Support Automation activities. • Support facilities and environmental programs. • Review and approve Work Orders. • Approve NC investigations and CAPA records. • Approve change controls. Education • Massters + 2 years of directly related experience or bachelors + 4 years of directly related experience or Associates + 8 years of directly related experience or High school/GED + 10 years of directly related experience. • Preferred: Bachelors in sciences with concentration in any science discipline such as Engineering, Biology, Chemistry, Physis, Computer, etc. More than 10 years in a biopharmaceutical industry with over 5 years in Quality, as a minimum.