SUMMARY Under general supervision, responsible for one or more of the following activities in Quality Control including analytical testing, characterization, method development, and sample and data management. This role is crucial for Amgen's success and it will be a key contributor in the Quality Control-Stability area supporting a non-standard shift operation that may include first, second, third and/or weekend shifts. SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: Perform routine laboratory procedures May perform aseptic aliquot ting, sampling and analysis for compendia and non-compendia methods May perform non-routine lab procedures under close supervision Perform or review one or more of the following: sample testing, standards preparation and testing procedures, compendia and non-compendia test methods, environmental monitoring, reagents and solutions preparation, sample management and equipment maintenance Prepare complete, accurate, concise laboratory documentation Data entry, review, analysis and communication of results Perform general lab housekeeping Maintain/operate specialized equipment Participate in the document revision process Comply with safety guidelines, cGMPs and other applicable regulatory requirements Maintain training proficiency Plan and perform routine analyses with greater efficiency and accuracy May provide technical guidance Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays Report, evaluate, back-up/archive, trend and approve analytical data Troubleshoot, solve problems and communicate with stakeholders Initiate and/or implement changes in controlled documents May train others as necessary Participate in audits, initiatives and projects that may be departmental or organizational in scope Write protocols and perform assay validation and equipment qualification/ verification Introduce new techniques to the lab, including method transfers, reports, validations and protocols May contribute to regulatory filings May conduct lab investigations as necessary Evaluate lab practices for compliance on a continuous basis Approve lab results May represent the department/organization on various teams May interact with outside resources Application of principles, concepts, theories and standards of technical/scientific field Specialized knowledge within own specialty area Deepens technical knowledge through exposure and continuous learning Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery Applies research, information gathering, analytical and interpretation skills to problems of diverse scope Ensures compliance within regulatory environment Develops solutions to technical problems of moderate complexity Screens, categorizes, evaluates, reconciles, reports and resolves data integrity issues Interprets generally defined practices and methods Works under general direction Work is guided by objectives of the department or assignment Refers to technical standards, principles, theories and precedents as needed May set project time-frames and priorities based on project objectives and ongoing assignments Recognizes and escalates problems Contributes to work group/team by ensuring the quality of the tasks/services provided by self Contributes to the completion of milestones associated with specific projects or activities within own department or workgroup Provides training/guidance to others and acts as a technical/scientific resource within work group/team Establishes working relationships with others outside area of expertise BASIC EDUCATION & EXPERIENCE Bachelor's degree & 2 years of quality and/or manufacturing industry experience OR Master's degree PREFERRED QUALIFICATIONS Educational background in Life Sciences and/or Engineering Quality industry experience Internal or external audits experience Method validation transfer Experience Basic Knowledge in device Previous experience with Stability program Availability to for business travel Technical writing experience/skills Project management skills Fully bilingual (English and Spanish) Strong organizational skills, including ability to follow assignments through to completion Initiate and lead cross functional teams Enhanced skills in leading, influencing and negotiating Strong knowledge in area of expertise Collaborate and coordinate with higher level outside resources Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development Demonstrate ability to interact with regulatory agencies Strong word processing, presentation, database and spreadsheet application skills Strong communication (both written and oral), facilitation and presentation skills Strong skill in working independently and to effectively interact with various levels Advance data trending and evaluation Ability to evaluate compliance issues Demonstrate the Amgen Values/Leadership Practices 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 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. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. 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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. 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, or disability status. .
