Specialist QA 34383

Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, the United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Administrative shift

Job Description:

Perform one or more of the following duties and responsibilities in support of the Quality Assurance program under minimal supervision.

Requirements:

•  Experienced quality assurance specialist.
• Commissioning and Qualification of Equipment/Systems/Facilities
• Auditing Equipment/Facilities/Utilities of Qualification Protocols and execution
• Revision and approvals of technical documents like URS, Design, Report of technical data.
• Deep knowledge of quality assurance terminology, methods, and tools
• Knowledge on Veeva, CDOCS applications.

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 and planned incidents
• Release of sanitary utility systems.
• Represent QA on NPI team.
• Lead investigations and site audits
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Review Risk Assessments.
• Support Automation activities and facilities and environmental programs.
• Review and approve work orders and EMS/BMS alarms.
• Approve NC investigations, change control and CAPA records
• 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.
•  Science or Engineering bachelor
• Pharmaceutical environment experience
•  Spoken languages: Spanish and English