Senior Associate Manufacturing Services (Day Shift) - ...

, 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.At Amgen, if you feel like youâre part of something bigger, itâs because you are. Our shared missionâ”to serve patients living with serious illnessesâ”drives all that we do.Since 1980, weâve helped pioneer the world of biotech in our fight against the worldâs toughest diseases. With our focus on four therapeutic areas â“Oncology, Inflammation, General Medicine, and Rare Diseaseⓠwe reach millions of patients each year. As a member of the Amgen team, youâll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youâll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.Senior Associate Manufacturing Services (Day Shift), What you will doLetâs do this. Letâs change the world. In this dynamic role, you will be a Senior Associate in the manufacturing organization at Amgen North Carolina (ANC). The schedule is a rotating 2-2-3, 12-hour shift.The Senior Associate will be executing operations on the floor in Manufacturing Services areas and is responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substance.The Senior Associate is responsible for executing on-the-floor operations within manufacturing in accordance with cGMP practices.Responsibilities will includeâ¦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 complianceInitiate deviation reportsInteract with regulatory agencies as needed and guidedAssure proper gowning and aseptic techniques are always followedProcess/Equipment/Facilities:Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment and assigned areaRun and monitor critical process tasks per assigned proceduresPerform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBR])Complete washroom activities: cleaning equipment, small to large scale, used in production activitiesIdentify, recommend, and implement innovative process improvements and optimizations related to daily routine functionsAssist in the review of 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 activitiesResponsible for recognizing and elevating problems during daily operationsParticipate in the implementation of programs and CAPAs (Corrective Action Preventive Action) with an eye toward continuous improvementDrive safety in all operations, and assist the manager in escalating concerns as neededMaintain an organized, clean, and workable spaceAdministrative:Draft and revise documents (SOPs, technical reports, and MPs)Interacts with management as an advisor in planning and in escalating potential concerns with the schedule and/or process

Created: 2025-11-10