Specialist QA

Experience as Specialist QA in Pharmaceutical GMP regulated manufacturing.

Responsibilities:

• 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.
  
• Designer 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

• Doctorate degree or Master degree and 3 years of directly related experience or Bachelor degree and 5 years of directly related experience Science / Engineering or related.
  
• Bilingual (English & Spanish)
  
• Technical Writing
  
• GMP and Manufacturing Process