Senior Associate IQA- Second Shift (Tuesday Thru ...

Job Details Job DescriptionJoin Amgens Mission of Serving PatientsAt Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.SENIOR ASSOCIATE IQA (INCOMING QUALITY)The new Amgen Advanced Assembly and Final Product Operation facility in Ohio is seeking a Senior Associate Quality Assurance for the incoming Quality team. The role will provide quality oversight for the GMP receiving area and be responsible for execution of raw material inspection, sampling, and disposition activities. The Incoming Quality Area is the area in the warehouse (owned by the QA team) where all materials needed for manufacturing of the finished drug product are sampled, inspected, and dispositioned before being used in any GMP operation. The incoming Quality team works closely with the supply chain planning organization and supplier quality management to ensure timely dispositioning of the raw materials that are required for finished drug product manufacturing at the facility. The Sr. Associate IQA will also provide support in ensuring compliant implementation of the quality management system within the incoming quality area and the warehouse area. This role will require local presence at the New Albany facility near Columbus, Ohio.What you will doLets do this. Lets change the world. At Amgen, we are committed to being science-based and follow a continuous learning approach to advancing science, driving discovery and igniting innovation that works to help reduce disease. It is in this context that we endorse an inclusive and diverse workforce that helps fuel scientific innovation and problem solving, leading to better scientific solutions that benefit both patients and society.In this vital role you will be responsible for sampling, inspection and dispositioning all raw materials received at the facility under general supervision. A key aspect of this role is to apply critical thinking skills to ensure quality and compliance to GMP regulations for all area operations and associated processes. Duties include batch record review, SOP creation & review, documentation, review & approval of minor deviations and CAPA records and batch disposition of raw materials.Responsibilities:Implement raw material sampling and inspection activities, including completion of GMP documentation to support raw material dispositionPerform raw material disposition ensuring that all quality deliverables are metProvide quality expertise & guidance and work with operations partners, supply chain and supplier quality management to resolve issues and ensure timely release of the raw materialsOwn and review controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and FormsOwn, investigate and approve quality records including deviations/CAPAs assuring adherence to procedural requirements and confirming assessments and evaluations of different collaborators are complete and accurate as neededFind opportunities for continuous improvement and implement improvements in partnership with other operations teamsProvide support during GMP Quality audits & inspectionsSupport Lean Transformation and Operational Excellence initiativesWhat we expect of youWe 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 these qualifications.Basic Qualifications:High school/GED + 4 years of Quality and/or GMP Manufacturing experienceORAssociates + 2 years of Quality and/or GMP Manufacturing experienceORBachelors + 6 months years of Quality and/or GMP Manufacturing experienceORMaster'sPreferred Qualifications:Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing TechnologiesExperience in and knowledge of GMP/GCP operations or similarly regulated industryAffinity with digital innovation, data sciences and Quality engineeringExperience with raw material receipt, inspection & samplingHighly effective verbal and written communication skills, strong interpersonal skillsGreat attention to detail and high degree of accuracy in GMP documentationAbility to complete tasks autonomously, providing updates to senior management, and identifying potential issuesStrong organizational skills, including ability to follow assignments through to completionDirect experience with Enterprise Resource Management software (SAP), TrackWise, CDOCS etc.What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models, including remote and hybrid work arrangements, where possibleApply now and make a lasting impact with the Amgen team.In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.CompanyWe are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world's leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide. We live the mission. We win together. We thrive on continual challenge. Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together-to research, manufacture and deliver ever-better products and greater depth to our mission. At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we're transforming the promise of science and biotechnology into therapies that have the power to restore health. Connect with us to explore how you can Win, Live, and Thrive at Amgen.Company info Website Phone 805-447-1000 Location Corporate HeadquartersOne Amgen Center Drive Thousand Oaks California 91320-1799 United StatesShare this job Facebook Twitter LinkedIn

Created: 2025-09-30