Specialist Qa- 33179

- 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.- Lead 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.Requisitos:Education: Doctorate degree or Master 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.Preferred Qualifications:• Perform Trackwise system queries, deviations• Participate in triage process• Perform oversight of the process and procedures/GMP tasks• Manage Change Controls and deviations for review and approval as QA contact• Work with operations to resolve basic compliance discrepancies• Knowledge in Validations and Laboratory area and equipment• Strong organizational skills, including ability to follow assignments through to completion.• Enhanced skills in leading, influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.• Microsoft Office spreadsheet and application skills and presentation knowledge.