What attributes (i.e. - preferred qualifications) would make this candidate stand out? Experience in Quality and Compliance, experience with validation protocols and reports for clean utilities, manufacturing processes, cleaning processes, equipment, computerized systems, change control records, deviations, etc. Experience in biological processes desired. SUMMARY Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision. FUNCTIONS Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Release of sanitary utility systems. Approve planned incidents. Lead investigations. Own site quality program procedures. Designee for QA manager on local CCRB. 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 OR Masters + 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. COMPETENCIES/SKILLS Strong organizational skills, including ability to follow assignments through to completion. Initiate and lead cross functional teams. Enhanced skills in leading, influencing and negotiating. Strong knowledge in area of expertise. Collaborate and coordinate with higher level outside resources. Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development. Demonstrate ability to interact with regulatory agencies. Strong word processing, presentation, database and spreadsheet application skills. Strong communication (both written and oral), facilitation and presentation skills. Strong skill in working independently and to effectively interact with various levels. Advanced data trending and evaluation. Ability to evaluate compliance issues. #J-18808-Ljbffr