Senior Associate Manufacturing Services - Night Shift

Role Summary

Senior Associate Manufacturing Services (Night Shift) at Amgen North Carolina. Responsible for on-the-floor manufacturing operations of cGMP drug substance in a 12-hour rotating shift (2-2-3). Focused on executing processes in Manufacturing Services areas in alignment with cGMP practices.

Responsibilities

• Complete work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) 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 (EBR)
• Complete washroom activities: cleaning equipment, small to large scale, used in production activities
• Identify, recommend, and implement innovative process improvements and optimizations related to daily routine functions
• Assist in the review of documentation for assigned functions (equipment logs, EBRs)
• Collaborate as part of a cross-functional team (QA/QC, F&E, PPIC, Mfg., PD, Regulatory, etc.) in completing production activities
• Recognize and elevate problems during daily operations
• Participate in the implementation of programs and CAPAs with an eye toward continuous improvement
• Drive safety in all operations, and assist the manager in escalating concerns as needed
• Maintain an organized, clean, and workable space

• Draft and revise documents (SOPs, technical reports, MPs)
• Interact with management as an advisor in planning and in escalating potential concerns with the schedule and/or process

Qualifications

• Basic Qualifications:
  • High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience OR
  • Associate‚Äôs Degree + 2 years manufacturing and/or other regulated environment experience OR
  • Bachelor‚Äôs Degree + 6 months manufacturing and/or other regulated environment experience OR
  • Master's Degree
• Preferred Qualifications:
  • Completion of NC BioWorks Certification Program
  • Experience in biotechnology or pharmaceutical plant start up
  • Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
  • Strong understanding of solution preparation, equipment preparation, and inventory control operations
  • Excellent verbal and written communication (technical) skills
  • Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems

Skills

• On-the-floor manufacturing operations
• cGMP compliance and documentation
• Process improvement and CAPA participation
• Cross-functional teamwork and communication
• Safety leadership and issue escalation

Education

• As listed in Basic Qualifications (see above)

Additional Requirements

• Night shift availability (rotating 2-2-3 schedule, 5:45 AM‚Äì6:15 PM)
• Willingness to work in a manufacturing setting with cGMP requirements