Specialist Qa

Job Description Summary Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision. 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. Requirements Bachelor’s degree in Sciences & 5 years of directly related experience Candidates for these positions should have experience within the manufacturing environment. Background in Quality Assurance directly related to manufacturing processes that include, but not limited to: Batch Record review, Non-conformances, Validation documentation, Facilities audit, general regulatory inspections. Available to 3rd shift

Ciudad: juncos