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Specialist QA 34063
InteldotJuncos, Puerto RicoHace 11 días
Descripción del trabajoExperience in reliability engineering, maintenance strategy, and process improvement. Working knowledge of pharmaceutical / biotech processes and ability to interpret and apply GLPs and GMPs. Familiarity with validation processes and documentation in a highly regulated environment. Manufacturing Equipment ownership at CMMS system (Work orders approval, closing, PM strategy, spare parts' definition / accuracy / updates), reliability and change control assessments and requirements. Responsible for enhancing system reliability focusing on equipment availability, downtime reduction, and maintenance optimization. Develop equipment performance metrics (availability, downtime, etc.) with emphasis on identifying equipment performance improvement opportunities. Lead the implementation of equipment improvement projects. SME (Subject Matter Expert) for systems regarding design, maintenance, and point of contact during compliance operations. Support equipment troubleshooting within the functional area or in the scope of technical expertise. Support deviation process and define, implement, and own CAPAs associated with equipment within area of expertise. 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. Strong communication (both written and oral), facilitation, and presentation skills. Strong skill in working independently and to effectively interact with various levels. Advanced data trending and evaluation. Ability to evaluate compliance issues. Demonstrate the Amgen Values / Leadership Practice
Inteldot has over 14 years in the life sciences industry with allocations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Job Description :
Perform one or more of the following duties and responsibilities in support of the Quality Assurance program under minimal supervision.
Non- standard Shift :
Monday – Friday 5 : 00 PM-5 : 30 AM
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.
Requirements and Responsibilities :
Competencies / Skills :
Education / Licenses :
Bachelor's degree and 5 years of directly related experience
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Specialist Qa • Juncos, Puerto Rico
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