Specialist QA

Job description

Career CategoryOperationsJob DescriptionJoin 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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer.  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. Quality Assurance Specialist What you will doLet’s do this.  Let’s change the world.  The Quality Assurance (QA) Technical Services Specialist is a critical role for the ARI site.  The QA Technical Services team provides quality oversight for the execution of key processes such as deviations, corrective actions, and change controls; as well as general quality partner support for functions outside of manufacturing (including PD, IS, and QC).  Because the function is engaged with complex investigations and delivery of site strategic priorities, the role offers the opportunity to engage broadly across the ARI site and within the network.  QA Specialists may be cross trained and/or assigned additional project specific duties, including continuous improvement initiatives, therefore, the ideal candidate will have demonstrated competencies across a broad range of quality-related disciplines.  This role demands a proactive and autonomous professional, capable of making risk-based decisions to uphold and improve our quality management system. Key Responsibilities include: Provide quality advice and oversight to ensure products are manufactured, tested, stored, and distributed according to current good manufacturing procedures. Serve as the ARI Subject Matter Expert (SME) for Deviation, CAPA, Change Control and risk management processes, responsible for monitoring QMS process health and performance, driving continuous improvement initiatives, providing technical and procedural expertise, and leading or supporting strategic projects to enhance compliance, effectiveness, and operational efficiency. Develop and maintain a working understanding of applicable requirements and best practices. Leverage knowledge and experience to provide risk-based Quality advice on strategies for successful investigation of deviations; as well as implementation of corrective actions, and change control Manage the quality processes, ensuring changes are thoroughly evaluated for impact to quality, and strategies for implementation follow Amgen’s processes and procedures. Perform review and approval of GMP processes, procedures, documents, and records, including deviations, corrective actions, change controls, effectiveness verifications, standard operating procedures, batch records, and protocols. Collaborate with project teams to integrate quality considerations and controls into project planning and execution. Independently assess and prioritize quality risks across various functions and processes. Implement proactive measures to prevent potential issues and ensure a state of inspection readiness Maintain relationships within the Amgen network to help benchmark and share best practices. Drive continuous improvement initiatives at the site and network level to create value for the business. This is an on-site role that offers flexibility based on business and team needs. Basic Qualifications High school diploma / GED & 10 years of Quality, Manufacturing, Process Development or Process Engineering experience OR Associate’s degree & 8 years of Quality,Manufacturing, Process Development or Process Engineering experience OR Bachelor’s degree & 4 years of Quality, Manufacturing, Process Development or Process Engineering experience OR Master’s degree & 2 years of Quality, Manufacturing, Process Development or Process Engineering experience OR Doctorate degree Preferred Qualifications: Deliver expert quality and technical support for the resolution of complex contamination control investigations and experience with environmental monitoring programs. Experience supporting Product Reintroductions (PRIs) and New Product Introductions (NPIs), ensuring robust quality system integration, supplier readiness, risk assessments, change control oversight, and seamless alignment with regulatory and inspection readiness expectations across global networks Demonstrated abilities in problem solving, and experience managing deviation/change control/ CAPA & risk management. Excellent written and verbal communication skills with cross functional teams, network, and management. Proven ability to make informed risk-based decisions to drive continuous improvement and maintain quality and compliance. Experience with Regulatory inspections. What you can expect from 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, we’ll 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 where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team.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 deadlineAmgen 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. SponsorshipSponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation. .Salary Range 104,287.35USD -141,094.65 USD