Quality Assurance Specialist - 2nd shift (3pm - 11:30pm)

Amgen

Allentown, PA

Estimated pay: Est. $20–$30/hr (market estimate, not employer-stated)

Shift: Full time

Career Category Quality Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Specialist Quality Assurance Location Easton, Pennsylvania - ON-SITE - Second Shift What you will do Let’s do this! Let’s change the world! This onsite position provides critical support for the Raw Material Center (RMC) warehouse, based in Easton, Pennsylvania. The RMC represents an advanced logistics solution designed to optimize the raw material network, serve three key manufacturing sites, f acilitat ing inventory pooling and bulk purchasing . RMC services encompass direct supplier receipt, incoming quality inspection and sampling, environmental monitoring, storage, and transportation. Responsibilities: Lead a second-shift team responsible for sampling and inspecting incoming raw materials from 3:00 p.m. to 11:30 p.m. Review documentation associated with receipt, storage, and distribution Evaluate documentation, determine and approve raw material lot disposition Ensure that all operations comply with relevant regulations and Amgen requirements, including Safety, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Documentation Practices Perform routine Quality Assurance assessments and provide direct operational oversight Offer leadership, guidance, mentorship, and training to staff and partner organizations Manage oversight of logistic and transportation service providers Provide expert advice on quality matters to operational teams and cross-functional groups Ensure staff complete necessary training related to Amgen business operations Achieve established metric targets and develop standardized approaches for tracking progress Collaborate with Logistic Service Providers (LSPs) to maintain service levels and identify areas for performance enhancement Present performance at business and quality management reviews a nd provide improvement plans as needed including updates on LSP Quality Management System health and initiatives Ensure facilities and team are inspection ready Represent the Quality Unit during audits and inspections, directly interacting with regulatory agencies Support internal and external audits and inspections as a member of the audit/inspection team Implement business continuity plans for services and processes as needed Create strategic partnerships with internal customers and external vendors to ensure operational success Integrate risk management strategies into overall supply chain management Lead initiatives, programs, and projects targeting operational improvements Develop solutions that are comprehensive, practical, and align with functional goals Perform additional duties as assigned by management What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications. Basic Qualifications: Doctorate degree OR Master’s degree and 2 years of quality assurance experience OR Bachelor’s degree and 4 years of quality assurance experience OR Associate’s degree and 8 years of quality assurance experience OR High school diploma / GED and 10 years of quality assurance experience Preferred Qualifications: Proven experience and proficiency in raw material incoming sampling and inspection operations Proven ability to communicate effectively with cross-functional teams and diverse cultures, both verbally and in writing Experience using AI tools and digitalization in day to day work proficiency in Microsoft 365 and experience in Power Platform Academic background in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies Skills in Continuous Improvement/Process Optimization Relevant experience in distribution, warehousing, manufacturing, validation, and engineering functions Expertise in managing deviations, change controls, and CAPAs Proficiency in Veeva, SM LIMS, and ERP systems Knowledge of industry standards (GMP, GDP, Import/Export) Commitment to exemplifying Amgen’s core values Demonstrated self-leadership and motivation Strong critical thinking skills Ability to eva