About this role
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. Associate Manufacturing - Bulk Drug Substance - Services - Day Shift Live What you will do 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 essential position, which supports our critical 24/7 manufacturing operations, works a 12-hour 2-2-3 schedule from 5:45am to 6:15pm. Associates will be completing operations on the floor in our manufacturing services area and will be responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substances. With general direction, the Associate will support all floor operations in accordance with cGMP practices. As Amgen relies upon the regular attendance of staff members to meet legitimate business needs, staff must be able to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime in support of our 24/7 operations. 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 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