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Qa Specialist 33124- 1873288
Title: Specialist QA 33124 🌟
Location: East of Puerto Rico 🌴
***Must be Resident of Puerto Rico***
Positions: 1️⃣
100% onsite work 🏢
Administrative shift 🕰️
Period: Approximately 1 year contract ⏳
SUMMARY:
Perform duties in support of Amgen's Quality Assurance program under minimal supervision. Educational background in Life Science and/or Engineering required.
Preferred Qualifications:
- Expertise in Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control) 📊
- Hands-on experience in electronic systems: 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 📝
- Validated experience as Quality Contact for sophisticated projects involving new drug substance/products with experience in commissioning and qualifications 🌱
- Enhanced skills in leading, influencing, and negotiating, with the ability to interact with regulatory agencies and evaluate compliance issues 💬
- Fully Bilingual in English and Spanish 🗣️
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:
- 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 Practices 🌟
Send us your updated resume to careers@proqualitynet.com with the title "Specialist QA 33124 Application" in the subject line. Don't miss out on this chance to be part of an innovative and dynamic team! 🚀
#CareerOpportunity #QAExpert
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