Job Description
Career CategoryQualityJob DescriptionJoin Amgen’s Mission of Serving PatientsAt 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.What you will doLet’s do this. Let’s change the world. In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation.This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for qualification/validation of each individual system/equipment; formulate independent decisions related to qualification/verification activities.ResponsibilitiesServe as Owner or QA Contact for Minor and Major Deviations. Review validation/qualification packages of computerized systems for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Bring critical exceptions or deviations to management’s attention and initiate and enforce necessary improvements and corrections to established systems and processes. Initiate, implement, and track completion of Change Control and deviation requests related to computer systems. Participation and support of regulatory inspections.Initiate and own QA Deviations (Major, Minor) as neededServe as QA contact for Major, Minor deviationsServe as Owner or QA contact for CAPA and Effectiveness Verification (EV) recordsServe as Quality approver for problem records in ServiceNowReview and approve Requirement Specifications, Design Specifications, Testing Protocols, Validation Plans, Summary Reports, and Requirement Traceability MatricesReview and approve operational and administrative SOPs and Work InstructionsReview and approve Change Controls (QA Contact role for CCMS and ServiceNow changes)Review and approve Data Integrity AssessmentsReview and approve System Life Cycle Documents (i.e. test protocols) before use in production.Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information (e.g., Qualitative information, Quantitative research, Trend data)Anticipates and prevents potential problemsMay be responsible for specific GxP Computerized Systems programs and/or projectsIndependently develops solutions that are thorough, practical and consistent with functional objectivesWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients.Basic Qualifications:Master’s degree and 4 to 6 years of Computer Science or related field and 5+ years of Software and Systems Quality assurance experience ORBachelor’s degree and 6 to 8 years of Computer Science or related field and 5+ years of Software and Systems Quality assurance experience ORDiploma and 10 to 12 years of Computer Science or related field and 5+ years of Software and Systems Quality assurance experiencePreferred Qualifications:Experience owning Major and Minor DeviationsTechnical knowledge of IS systems such as LIMS, CDOCS, SAP, MaximoAbility to interpret and apply GxP (GMP, GLP, GCP, GPvP, GDP)Broad technical knowledge within own specialty areaKnowledge of industry and business principlesDemonstrated problem solving abilitiesContributes to work group/team by ensuring quality of tasks/ services provided by self and othersProvides training and guidance to othersExtends capabilities by working closely with senior staff/ experts within and outside the internal organizationExperience serving as QA Contact for Major and Minor DeviationsExperience in GxP computerized systems validationWhat 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, we’ll 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 nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAs 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..
