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
What We Do
Inteldot offers custom turn-key systems, systems integration, MES eBR configuration and integration solutions, business intelligence and analytics and technical staffing.
We have been providing the Pharmaceutical, Manufacturing and Medical Device industries with services for a variety of applications since 2004
