Sr Specialist QA

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