The Specialist QA will 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.
Master’s degree and 3 years of project experience or Bachelor’s degree and 5 years of related experience.
Ultimate Solutions Corp is an equal opportunity employer.
- Experience in Biotech or Pharmaceutical Industry
- Experience working with Quality Systems
- Equipment Qualification
- Cleaning and Process Validation
- Change Controls