Qa Specialist 33226- 1998221

Title: Specialist QA (Drug Substance) 33226 🌟

SUMMARY:

Join our dynamic team and contribute to Amgen's Quality Assurance program with minimal supervision. This role offers hybrid/virtual/remote work on an administrative shift basis for approximately one year.

Preferred Qualifications:

• Educational background in Life Science and/or Engineering 📚
• Trackwise system queries, deviations proficiency 🛠️
• Participate in triage process 🔍
• Oversight of process/procedures/GMP tasks 🧪
• Manage Change Controls and deviations for QA approval 📋
• Resolve basic compliance discrepancies with operations 🌐
• Knowledge in Validations and Laboratory area/equipment 🧪
• Strong organizational skills with task completion focus 📝
• Leading, influencing, negotiating skills with regulatory agency interaction 🤝
• Microsoft Office proficiency and bilingual in English and Spanish 📊🗣️
• Strong communication (written/oral) and presentation skills 🗣️💼

FUNCTIONS:

• Review and approve product MPs ✔️
• Approve process validation protocols and reports ✔️
• Request Quality on incident triage team ✔️
• Approve Environmental Characterization reports ✔️
• Release 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 ✔️

EDUCATION/LICENSES:

• Doctorate/Master's degree with 3 years related experience
• Bachelor's degree with 5 years related experience
• Associate's degree with 10 years related experience
• High school diploma/GED with 12 years related experience

COMPETENCIES/SKILLS:

• Project management skills 📊
• Organizational skills for task completion 📋
• Lead cross-functional teams 🤝
• Leading, influencing, negotiating skills 🌟
• Knowledge in QA, QAL, validation, process development 🧪
• Interact with regulatory agencies 🏛️
• Microsoft Office proficiency 📊
• Communication and presentation skills 🗣️💼
• Work independently and interact effectively with all levels 🌟
• Data trending and evaluation skills 📈
• Evaluate compliance issues 📊
• Demonstrate the Amgen Values/Leadership Practices 🌟

Join our dynamic team and take the next step in your career by sending us your updated resume today!