Associate Manufacturing (Night Shift) - Multiple Positions

Role Summary

Associate Manufacturing (Night Shift) at Amgen North Carolina (ANC). This 12-hour 2-2-3 shift (5:45 pm to 6:15 am) supports our critical 24/7 manufacturing operations and the production of cGMP drug substances on the floor in the manufacturing services area. The role requires completing operations in accordance with cGMP practices and collaborating with cross-functional teams to maintain safe, compliant, and efficient production.

Responsibilities

• Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance
• Assure proper gowning and aseptic techniques are always followed
• Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment in assigned area
• Run and monitor critical process tasks per assigned procedures
• Buffer and Media preparation and transfer
• Weigh and dispense of materials to be used in the preparation of Buffers and Medias
• Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs])
• Complete washroom activities: cleaning equipment, small to large scale, used in production activities
• Identify and escalate issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions
• Perform documentation for assigned functions (i.e., equipment logs, EBRs)
• Collaborate as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities
• Maintain an organized, clean, and workable space

Qualifications

• Required: High School/GED + 2 years manufacturing and/or other regulated environment experience OR
• Required: Associate’s Degree + 6 months manufacturing and/or other regulated environment experience OR
• Required: Bachelor’s Degree
• Preferred: Completion of NC BioWork Certificate Program
• Preferred: Experience in a regulated industry such as biotechnology or pharmaceutical
• Preferred: Basic understanding and process experience in a cGMP manufacturing facility
• Preferred: Excellent verbal and written communication
• Preferred: Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, DeltaV, and Electronic Quality Systems
• Preferred: An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes

Skills

• Excellent verbal and written communication
• Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, DeltaV, and Electronic Quality Systems
• An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes