We are seeking a Sr. Specialist QA to support Quality Assurance program acts as the technical specialist. Review and approve product MPs. FUNCTIONS - Approve process validation protocols and reports for mfg. processes. - Represent Quality on incident triage team. - Approve Environmental Characterization reports. - Release of sanitary utility systems. - Approve planned incidents. - Represent QA on NPI team. - Lead investigations. - Own site quality program procedures. Requirements Education: Doctorate + 2 years of directly related experience or Masters + 4 years of directly related experience or Bachelors + 6 years of directly related experience or Associates + 10 years of directly related experience or High school/GED + 12 years of directly related experience. Experience with: Facilities and Utilities Commissioning and Qualification Computer System Validation Equipment validation Risk Assessments KNEAT,CDOCS, SCADA, TRACKWISE,MAXIMO Good Documentation Practices, Data Integrity Change Controls Standard Operation Procedure Syringe/Vials Inspection Process Documents revision and approval Strong knowledge of Decision Making Techniques Risk Management
QRC group is a life science firm dedicated to provide services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Our services and solutions include:
Process and Laboratory Investigation
• Corrective and Preventive Action (CAPA)
• Change Control
• Training
• Document Management Control
• QA Laboratory
• Methodology Transfer and Validation
• Instrument Calibration
• Validation and Training in Chromatographic Data Acquisition System
• Cleaning Validation
• Automation Engineering
• Quality Systems
