Specialist QA ID33727

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 in Puerto Rico. 

Description:

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

Functions: 

• 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: 

• Fluent in English and Spanish, including writing
• Strong English technical writing skills
• Project management skills.
• Strong organizational skills, including ability to follow assignments through to completion.
• Initiate and lead cross functional teams.
•  Enhanced skills in leading, influencing and negotiating.
• Strong knowledge in area of expertise.
• Collaborate and coordinate with higher level outside resources.
• Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
• Demonstrate ability to interact with regulatory agencies.
• Strong word processing, presentation, database and spreadsheet application skills.

Education: 

Master’s degree and 3 years of Quality and/or Manufacturing experience Or Bachelor’s degree and 5 years of Quality and/or Manufacturing experience Or
Associate’s degree and 10 years of Quality and/or Manufacturing experience