Specialist QC

Join 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. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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. Specialist QC What you will do Let's do this. Let's change the world. In this vital role you will provide leadership and support for QC Centralized Raw Material Testing in the Instrumentation Laboratory at Amgen Rhode Island. The Specialist QC will contribute directly and provide support to core laboratory operations, including: Routine Raw Material Testing Review/Approval of results in LIMS Interfacing with CTLs and entering results in LIMS Support for troubleshooting and problem solving Support for method validations Oversight of material onboarding Lab Point of Contact for Compendial Compliance Site SME for instrumentation methods, procedures, equipment, etc. Support with quality records (e.g. TRA ownership, Minor deviation initiation, and SME for Major deviations) Document ownership for Raw Material testing procedures Provide leadership by mentoring and coaching team Instructor for multiple methods/equipment Presents during audits and inspections What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a self-starter with these qualifications.

Basic Qualifications :

High school diploma / GED and 10 years of Quality or Operations experience OR Associate's degree and 8 years of Quality or Operations experience OR Bachelor's degree and 4 years of Quality or Operations experience OR Master's degree and 2 years of Quality or Operations experience OR Doctorate degree

Preferred Qualifications:

Experience leading teams, projects, programs or directing the allocation of resources Experience executing analytical testing per Methods and/or Compendia Experience with QC analytical systems and/or Quality systems Excellent interpersonal, written and verbal communication skills with all levels within the organization Ability to work in a team matrix environment and build relationships with partners Identify, manage, and champion innovative projects to advance productivity and enable LEAN principles across different functions Experience in auditing and defending processes, procedures and decisions during regulatory inspections Strong leadership and negotiation skills with a demonstrated ability to influence different styles Strong quality mindset Demonstrated innovative thinking and ability to transform work organizations Strong technical writing skills within a highly regulated environment Demonstrated ability to navigate through ambiguity and provide a structured problem solving Demonstrated ability to coordinate multi-functional project teams and deliver on schedule What you can expect of 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, 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 deadline 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. Sponsorship Sponsorship 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 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.