Specialist Quality Assurance

Career Category Quality Job Description Join Amgen? Mission of Serving Patients At Amgen, if you feel like you?e part of something bigger, it? because you are. Our shared mission?o serve patients living with serious illnesses?rives all that we do. Since 1980, we?e helped pioneer the world of biotech in our fight against the world? toughest diseases. With our focus on four therapeutic areas ?ncology, Inflammation, General Medicine, and Rare Disease?we reach millions of patients each year. As a member of the Amgen team, you?l 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?l thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Specialist Quality Assurance What you will do Let? do this. Let? change the world. In this vital role you will be responsible for sophisticated or innovative projects involving strategic planning, development and execution of Software Development Lifecycle deliverables. The candidate will be involved in all phases of computerized systems validation/assurance; planning, requirements, testing (e.g. IQ, OQ), and approval of documentation supporting the process. The candidate will offer guidance, technical information and work optimally in a collaborative environment to meet organization goals. Responsibilities Take ownership and accountability as a Quality Assurance for records/tasks assigned. Evaluate validation and qualification packages of computerized systems to ensure they are complete, accurate, and meet regulatory expectations. Ensure compliance with validation policies and procedures and conduct thorough data analysis to compare results against acceptance criteria. Collaborate with various organizations to resolve challenges/issues, raise critical issues to management's attention. Initiate, Review and Approve Change Controls as QA contact (e.g. TrackWise/Veeva, ServiceNow) Initiate, Review and Approve deviations (Minor & Major) Review and Approve problem records in ServiceNow Serve as Owner or QA contact for CAPA and Efficiency Verification (EV) records Review and Approve Validation documentation Review and Approve operational, administrative SOPs and Work Instructions Review and Approve Data Integrity Assessments (DIA) Review and Approve System Periodic Review & Audit Trail Supports Continuous improvement activities and initiatives Supports Training initiatives and strategy as needed Supports the Management Review Process as needed Supports the Integrated Systems Assessment (ISA) Process as needed Supports Supplier Evaluations as needed Participate in and support regulatory inspections as needed What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master? degree and 4 to 6 years of technical field experience OR Bachelor? degree and 6 to 8 years of technical field experience OR Diploma and 10 to 12 years of technical field experience Preferred Qualifications: Work Experience: 3- 5 demonstrated ability in Computer System Validation, Quality Assurance processes in a regulated industry (preferred Biotechnology/Pharmaceutical) Demonstrated experience in the validation of computerized systems Demonstrated experience in handling quality assurance processes Regulatory experience: Ability to interpret and apply GxP regulations, including GMP, GLP, GCP, GPvP, and GDP standards Technical experience: Extensive technical knowledge of Information Systems such as LIMS, CDOCS, SAP, and Maximo. Problem-Solving: Strong analytical and problem-solving skills, capable of addressing and resolving sophisticated quality issues using multiple sources of information (e.g., Qualitative information, Quantitative research, Trend data) Strong decision-making skills and can handle and drive tasks to completion Independent and can work with minimal day to day supervision Leadership: Can lead a project, assigned tasks or group of individuals as required What you can expect of us As we work to develop treatments that deal with others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we?l support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies creativity Objects in your future are closer than they appear. Join us. careers.amgen.com 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 committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

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