Specialist QA

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

Description: 

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

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. 
• 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. 

Competencies / Skills: 

• Expertise in Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control). 
• Hands on experience in electronic systems for instance: Documentation platforms (CDOCS), Maximo, Trackwise, LIMS, electronic batch record (MES) and SAP. 
• Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements. 
• Validated experience as Quality Contact for sophisticated projects involving new drug substance/products with experience in commissioning, facility, utility, and equipment qualifications. 

Education: 

• Master's degree and 3 years of directly related experience o Bachelor's degree and 5 years of directly related experience years of directly related experience.

Compensation and Benefits: 

• Employment (W2) and Professional Services Contract (480) available. 
• Administrative, as per business need.
• Competitive Pay Rate