Manufacturing Associate, Bulk Drug Substance - Holly Springs, NC

Manufacturing Associate, Bulk Drug Substance Upstream - Days

Let's do this! Let's change the world! In this dynamic role, you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC). The schedule is a rotating 2-2-3, 5:45AM-6:15PM (12-hour shift). Associates will be completing operations on the floor in our upstream area and are responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substance.

With general direction, the Associate will support all floor operations in accordance with cGMP practices. Responsibilities will include:

• Compliance: 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.
• 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 (Electronic Batch Records [EBRs]). 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.

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