Senior Associate Manufacturing Services - Night Shift
Amgen
Full-time
On-site
Holly Springs, NC
Operations
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Role Summary
Senior Associate Manufacturing Services (Night Shift) responsible for on-the-floor manufacturing operations of cGMP drug substance at Amgen North Carolina, following cGMP practices on a rotating 12-hour shift.
Responsibilities
- Compliance: complete work in accordance with cGMP procedures and policies (SOPs, MPs, JHAs, CFR), with strict adherence to safety and compliance; initiate deviation reports; interact with regulatory agencies as needed; ensure proper gowning and aseptic techniques.
- Process/Equipment/Facilities: perform hands-on operations including set-up, cleaning, sanitization, and monitoring of equipment; run and monitor critical process tasks; perform in-process sampling, operate analytical equipment, and complete process documentation (EBR); complete washroom activities; identify, recommend, and implement process improvements; assist in documentation review; collaborate with cross-functional teams; recognize and elevate problems; participate in CAPAs; drive safety; maintain an organized workspace.
- Administrative: draft and revise documents (SOPs, technical reports, MPs); advise management on scheduling and process concerns.
Qualifications
- Required: High School Diploma/GED + 4 years manufacturing or regulated environment experience OR Associate’s Degree + 2 years experience OR Bachelor’s Degree + 6 months experience OR Master’s Degree.
- Preferred: NC BioWorks Certification Program; experience in biotechnology or pharmaceutical plant startup; knowledge of cGMP manufacturing facilities; strong understanding of solution preparation, equipment preparation, and inventory control; excellent verbal and written technical communication; proficient Microsoft Office and knowledge of EBR/MES, Delta V, and Electronic Quality Systems.
Skills
- Technical writing and documentation
- Cross-functional collaboration (QA/QC, F&E, PPIC, Mfg., PD, Regulatory)
- On-the-floor manufacturing operations in a cGMP environment
- Problem recognition and CAPA participation
- Safety leadership and continuous improvement mindset
Education
- As listed under Qualifications: include any applicable degree or certification.
Additional Requirements
- Night shift availability; 2-2-3 rotating schedule