Associate Manufacturing (Day Shift)

Role Summary

Associate Manufacturing (Day Shift) at Amgen North Carolina. You will be part of the manufacturing organization, performing floor operations in manufacturing services, upstream or downstream areas, and responsible for manufacturing of cGMP drug substance. Initial schedule is 10-hour shifts Monday to Friday from 6am to 4pm, transitioning to a 12-hour night shift with every other weekend as needed.

Responsibilities

• Compliance:
• Completes work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance
• Assure proper gowning and aseptic techniques are always followed
• Process/Equipment/Facilities:
• 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 (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 (QA/QC, F&E, PPIC, Mfg., PD, 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
• Required: Associate’s Degree + 6 months manufacturing and/or other regulated environment experience
• 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, Delta V, and Electronic Quality Systems
• Preferred: An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes

Education

• Bachelor’s Degree