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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Sr. Associate Plant QA 12 Night Shift (6pm- 6:30am) - **Company:** Amgen - **Location:** New Albany, OH, United States - **Experience:** Expert - **Salary:** $82,082.0 - $111,052.0 - **Contract:** Permanent contract - **Skills:** SAP (Applications), Trackwise - **Published:** September 11, 2026 - **Apply:** https://www.careerjet.com/job/us584d1e0f819e11b65e899e8b16097bd0/eaa ## About the Role High school/GED + 4 years of Quality and/or GMP Manufacturing experience OR Associate's + 2 years of Quality and/or GMP Manufacturing experience OR Bachelor's + 6 months of Quality and/or GMP Manufacturing experience OR Master's Preferred Qualifications: Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies Experience in and knowledge of GMP/GCP operations or similarly regulated industry Affinity with digital innovation, data sciences and Quality engineering Experience with raw material receipt, inspection & sampling Highly effective verbal and written communication skills, strong interpersonal skills Great attention to detail and high degree of accuracy in task execution and GMP documentation Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues Strong organizational skills, including ability to follow assignments through to completion Direct experience with Enterprise Resource Management software (SAP), TrackWise, CDOCS etc. ## Description Let's do this. Let's change the world. In this role As Senior Associate Plant QA, you will be working in a shift system; you will be mainly responsible for providing QA guidance and support to AOH production, and you will be performing Quality Batch Record Review of all commercial batches labelled and packed at AOH. Next to that, you will provide support in different QA related projects/systems. In this role, you will be in direct contact with a wide range of stakeholders, and you will be responsible for establishing effective working relationships with production operators, production line leads, production shift supervisors, warehouse, facilities, maintenance and engineering. Responsibilities Let's do this. Let's change the world. In this vital role you will: Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures and Work Instructions. Ensure regular presence in device assembly and packaging areas to monitor GMP operations and quality systems. Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations. Lead, mentor, and coach Operations and support personnel on quality matters, while driving the site Quality culture. Review and approve batch production record and other GMP documentation in support of daily operations. data entries before production activities take place Perform finished product checks during (commercial) production runs Compile and review batch records for lots assembled, packaged and labeled at AOH in preparation for batch disposition. Own, review, and approve controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and Forms. Review and approve Deviation, CAPA, and Change Control records. Participate in self-led inspections and provide support during internal / external regulatory inspections. Support Lean Transformation and Operational Excellence initiatives Adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting EHSS corporate and site goals. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a dynamic, flexible and driven individual with any of these qualifications. ## Related Videos - [Self-service Quality: QA Without QA](https://www.wearedevelopers.com/videos/100184-self-service-quality-qa-without-qa) - [Independently together: how micro-applications improve developer experience + app performance](https://www.wearedevelopers.com/videos/452-independently-together-how-micro-applications-improve-developer-experience-app-performance) - [Replacing Excel with SAP APIs & Python validation](https://www.wearedevelopers.com/videos/1944-replacing-excel-with-sap-apis-python-validation) - [Remote Driving on Plant Grounds with State-of-the-Art Cloud Technologies](https://www.wearedevelopers.com/videos/251-remote-driving-on-plant-grounds-with-state-of-the-art-cloud-technologies) - [Designing How Work Feels: The Science Behind Sanofi’s Workplace Experience](https://www.wearedevelopers.com/videos/1848-designing-how-work-feels-the-science-behind-sanofi-s-workplace-experience) - [Snappy UI needs no Single-Page Application](https://www.wearedevelopers.com/videos/904-snappy-ui-needs-no-single-page-application) ## Related Articles - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [Where to Find Entry-Level Software Engineering Jobs](https://www.wearedevelopers.com/magazine/397-where-to-find-entry-level-software-engineering-jobs) - [How Much FAANG Companies Actually Pay Software Engineers in 2025](https://www.wearedevelopers.com/magazine/230-how-much-faang-companies-actually-pay-software-engineers-in-2025) - [How to land a developer job in Amsterdam](https://www.wearedevelopers.com/magazine/36-how-to-land-a-developer-job-in-amsterdam) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers)