Qa Specialist - 33271

Title: Specialist QA 33271 (Pharmaceutical/Biotech Industry)

📍 Location: Juncos, PR

🏢 Work: 100% onsite with non-standard shifts

The shifts are:

500 AM – 1:30 PM

1:00 PM – 9:30 PM

9:00 PM – 5:30 AM

📅 Duration: Approximately 2 years

👥 Positions Available: 3

SUMMARY

🔍 Perform various duties and responsibilities in support of Amgen's Quality Assurance program under minimal supervision.

📚 Educational/Software Requirements:

• 🎓 Doctorate degree, or
• 🎓 Master's degree and 3 years of directly related experience, or
• 🎓 Bachelor's degree and 5 years of directly related experience, or
• 🎓 Associate's degree and 10 years of directly related experience, or
• 🎓 High school diploma/GED and 12 years of directly related experience.

Preferred Qualifications:

• 📦 Knowledge in Warehouse and Incoming QC operations
• 📋 Experience with quality oversight and quality records such as deviations, CAPAs, and change controls

FUNCTIONS:

• 📝 Review and approve product MPs
• ✔️ Approve process validation protocols and reports for manufacturing processes
• 🚨 Participate in incident triage teams
• 🌿 Approve Environmental Characterization reports
• 💧 Release sanitary utility systems
• 🗂️ Approve planned incidents
• 👥 Represent QA on NPI teams
• 🔍 Lead investigations and site audits
• 🏆 Own site quality program procedures
• 👤 Act as 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, with the ability to follow assignments through to completion
• 👥 Ability to initiate and lead cross-functional teams
• 💬 Enhanced skills in leading, influencing, and negotiating
• 📚 Strong knowledge in area of expertise
• 🤝 Ability to collaborate and coordinate with higher-level outside resources
• 🔬 Strong understanding of manufacturing, distribution, QA, QAL, validation, and process development processes
• 🏛️ Demonstrated ability to interact with regulatory agencies
• 💻 Proficiency in word processing, presentation, database, and spreadsheet applications
• 🗣️ Excellent communication (both written and oral), facilitation, and presentation skills
• 👤 Ability to work independently and effectively interact with various levels
• 📊 Advanced data trending and evaluation skills
• ✅ Ability to evaluate compliance issues
• 🌟 Demonstrate the Amgen Values/Leadership Practices

📧 If you are a qualified candidate looking for a rewarding opportunity, please send your updated resume to careers@proqualitynet.com with the subject line "Specialist QA 33271". We look forward to hearing from you! 💼