Specialist QA

Join Amgens Mission of Serving Patients At 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. Location Q3 2024 Q1 2025: Remote or Louisville Distribution Center (LDC), Kentucky Q2 2025 Forward: Easton, Pennsylvania - ON-SITE Specialist QA What you will do Lets do this. Lets change the world. In this vital role you will implement and oversee a new Raw Material Center Plus (RMC) warehouse. RMC is a logistics solution being implemented to facilitate raw material network optimization; to serve more manufacturing sites, and to enable inventory pooling and bulk purchasing. RMC services will include direct receipt from suppliers, incoming quality inspection and sampling, environmental monitoring, storage, and transportation. This position will be responsible for logistic service provider and transportation service provider oversight, Quality Management System Process alignment, and process improvement activities. Responsibilities: Have oversight of small team of QA professionals Ensure operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Distribution Practices, Good Documentation Practices, and Safety Collaborate with the LSP to ensure adherence to service levels, identifying performance improvement opportunities in alignment with the Operations READ framework (reliability, efficiency, agility, differentiation) Implement business continuity for services and processes Partner with key internal customer groups and/or outside vendors to ensure successful operations Participate / Conduct quarterly Amgen Business / Quality reviews and address service failures with the LSP Ensure metric targets are achieved and establish standardized mechanisms to measure progress against targets Understand and incorporate risk management strategy into overall supply chain strategy Ensure compliance with required training for staff supporting Amgen business Provide leadership, guidance, mentorship, and training to staff and partner groups Perform receipt, storage, and distribution documentation review to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations Perform cGMP process, procedure, document and record review, and approval, including but not limited to deviations, CAPAs, change controls, risk assessment, and validation records Perform incoming raw material inspection, environmental monitoring, and documentation review Provide leadership updates regarding the health and initiatives relating to the QMS at site management reviews Provide logistic service provider and transportation service provider oversight Represent the Quality Unit during audits and inspections and directly interact with regulatory agencies during on-site inspections Support internal/external audits and inspections as part of the audit/inspection team Perform routine Quality Assurance assessments of operations and provide direct oversight Provide quality expertise and guidance to operational staff and within cross functional Amgen teams Drive operational improvement initiatives, programs, and projects Develop solutions that are thorough, practical, and consistent with functional objectives Perform additional duties as specified by management What we expect of you We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have these qualifications. Basic Qualifications: Doctorate degree Or Masters degree and 2 years of quality experience Or Bachelors degree and 4 years of quality experience Or Associates degree and 8 years of quality experience Or High school diploma / GED and 10 years of quality experience Preferred Qualifications: Ability to liaise/communicate effectively and easily with cross-functional teams and different cultures (excellent written and verbal communication skills) Self-leadership and motivation Strategic mindset Serves as a role model for Amgen Values Understanding of industry requirements (GMP, GDP, Import/Export) Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies Previous QA oversight of distribution, warehousing, incoming QA, manufacturing, validation, and facility and engineering activities Experience in deviation, change controls, and CAPAs processes system knowledge Ability to evaluate compliance issues and interact with regulatory inspectors Experience and training in Veeva, SM LIMS, ERP Experience in managing multiple, competing priorities in a fast-paced environment Experience leading and/or managing teams Direct drug substance and/or drug product experience Ability to solve complex problems and make scientific risk-based decisions Experience representing Amgen while interacting with representatives of regulatory agencies Demonstrated proficiency using Excel, Word, and PowerPoint What you can expect from us As 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 accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com 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. Application deadline External/Internal postings: Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. 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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. 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.