Associate Manufacturing (Day Shift)
Amgen
Full-time
Remote friendly (Holly Springs, NC)
United States
Operations
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Role Summary
Associate Manufacturing (Day Shift) at Amgen North Carolina. Responsible for manufacturing cGMP drug substance in a floor operations environment, supporting all aspects of manufacturing services in upstream or downstream areas with adherence to cGMP practices. Initial schedule is 10-hour shifts Monday to Friday 6am–4pm, transitioning to a 12-hour night shift with every other weekend as needed.
Responsibilities
- Compliance: Complete work in accordance with established cGMP procedures and policies, including SOPs, MPs, JHAs, and CFR, with strict adherence to safety and compliance; ensure proper gowning and aseptic techniques.
- Process/Equipment/Facilities: Perform hands-on operations including setup, cleaning, sanitization, and monitoring of equipment and area; run and monitor critical process tasks; perform in-process sampling, operate analytical equipment, and complete process documentation (EBRs); complete washroom activities; identify and escalate issues; document functions (equipment logs, EBRs); collaborate with cross-functional teams; maintain organized workspace.
Qualifications
- Required: High School/GED + 2 years manufacturing or other regulated environment experience; or Associate’s Degree + 6 months experience; or Bachelor’s Degree.
- Preferred: NC BioWork Certificate Program; experience in biotechnology or pharmaceutical regulatory environment; basic understanding and process experience in a cGMP manufacturing facility; excellent verbal and written communication; proficiency with Microsoft Office and electronic systems (EBR/MES, Delta V, Electronic Quality Systems); demonstrated willingness to learn and grow in operations.
Skills
- cGMP compliance and documentation
- Hands-on manufacturing operations
- Analytical equipment operation and data/EBR handling
- Cross-functional collaboration
- Strong communication
Education
- High School/GED, Associate’s Degree, or Bachelor’s Degree (as listed in qualifications)
Additional Requirements
- Ability to work 10-hour days (Mon–Fri 6am–4pm) with potential transition to 12-hour night shifts and weekend work as business needs dictate