Specialist Qa - Quality System

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/Engineering and 5 years of directly related experience Strong Negotiation and communication Skills Working in a complex network environment Quality Management System Requirements experience Additional Preferred experience: Previous experience managing documents in EDM Quality Project Management Skills/Writing controlled documents (templates) Knowledge of Regulatory Requirements for GMP documents. Company Description PRPDG has been providing top-notch consulting services based on decades of experience. The company is armed with a staff of seasoned professionals equipped to meet the challenge of completing projects be they short-term contracts or long-term projects on time and under budget, to the cent.