Senior Associate Manufacturing Services - Night Shift

Role Summary

Senior Associate Manufacturing Services (Night Shift) at Amgen North Carolina (ANC). 12-hour rotating shift (5:45 AM–6:15 PM) on a 2-2-3 schedule. Responsible for on-the-floor manufacturing of cGMP drug substance and execution of operations within Manufacturing Services in accordance with cGMP practices.

Responsibilities

• Complete work in accordance with established cGMP procedures and policies with strict adherence to safety and compliance
• Initiate deviation reports
• Interact with regulatory agencies as needed and guided
• Assure proper gowning and aseptic techniques are always followed
• Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment and assigned area
• Run and monitor critical process tasks per assigned procedures
• Perform in-process sampling, operate analytical equipment, and complete process documentation
• Complete washroom activities: cleaning equipment, small to large scale, used in production activities
• Identify, recommend, and implement process improvements and optimizations related to daily routine functions
• Assist in the review of documentation for assigned functions (equipment logs, documentation)
• Collaborate with cross-functional teams to complete production activities
• Recognize and elevate problems during daily operations
• Participate in CAPAs with focus on continuous improvement
• Drive safety in all operations and escalate concerns as needed
• Maintain an organized, clean, and workable space
• Draft and revise documents (SOPs, technical reports, and MPs)
• Interact with management as an advisor in planning and escalating potential concerns with the schedule/process

Qualifications

• Basic Qualifications:
  • High School Diploma/GED + 4 years manufacturing or regulated environment experience
  • Associate‚Äôs Degree + 2 years manufacturing or regulated environment experience
  • Bachelor‚Äôs Degree + 6 months manufacturing or regulated environment experience
  • Master's Degree
• Preferred Qualifications:
  • Completion of NC BioWorks Certification Program
  • Experience in biotechnology or pharmaceutical plant startup
  • Knowledge of cGMP manufacturing facility or other highly regulated environment
  • Understanding of solution preparation, equipment preparation, and inventory control
  • Excellent verbal and written technical communication
  • Proficient Microsoft Office; experience with EBR/MES, Delta V, and Electronic Quality Systems