Inteldot has over 14 years of experience in the life sciences industry, with allocations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Job Description
Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision.
Administrative Shift but available weekends
Requirements:
- Quality Professional with New Product Introduction (NPI) experience
- Experience with validation and change control activities
- Knowledge with DAI process, PASx/MES application, Risk assessment, MAXIMO, SAP and LIMS
Funtions:
- 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.
- Lead investigations and site 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.
- Review and approve EMS/BMS alarms.
- Approve NC investigations and CAPA records.
- Approve change controls.
- Provide lot disposition and authorize lots for shipment.
Education:
- Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.