Job
Description
PRODUCT QUALITY SPECIALIST What you will do Let’s do this. Let’s change the world. In this vital role you will provide technical expertise and product leadership to the Product Quality (PQ) organization. As a product support staff in Quality, the Product Quality Specialist has responsibility for working with Product Quality Leaders (PQL), International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other groups on projects including support of product specifications, in-process controls, periodic and annual product review, and complaint resolutions. Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies we’re employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients. This role will support one or more late-stage and/or commercial biologics or synthetics products. The individual will provide project support to the relevant Product Quality Team (PQT) to implement and manage strategy for Quality to meet the Product Quality goals. The individual will be directly responsible for Product Quality related tasks including authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (document management system, complaint resolution system, data systems), and product data management, including stability, comparability assessments, periodic and annual product reviews (APR). In addition, the candidate will be expected to play a role in supporting Product Quality initiatives intended to ensure the overall product health. Support PQ work for late-stage and/or commercial biologic or synthetic programs, including actions required for the PQT, APR, specifications, comparability, stability programs, and PQ owned regulatory filing sections and responses to questions (RTQ) Support science and risk-based evaluation of complex process and product quality data such as in-process, release and stability data, complaints, method performance etc. What we expect of you Basic Qualifications and Experience: Doctorate degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 2 years of Quality, Operations, Scientific, or Manufacturing experience, or Master’s degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 6 years of Quality, Operations, Scientific, or Manufacturing experience, or Bachelor’s degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 8 years of Quality, Operations, Scientific, or Manufacturing experience or Preferred Qualifications: Must-Have Skills: Demonstrate proficiency in oral and written communication of complex information to Product Quality team members and peers Demonstrate proficiency in knowledge of cGMP and international regulatory expectations Strong scientific data management and organization skills with attention to detail Ability to deliver high quality results and adhere to project timelines using computer-based GMP Quality systems Ability to build and maintain multi-functional relationships and strong partnerships through written and verbal communication skills Good-to-Have Skills: Experience working virtually on a multi-functional team in a matrix environment across multiple time zones Expertise in computer applications such as Veeva, Spotfire, SHINY Expertise in MS Office (Word, Excel, PowerPoint, MS Teams) Soft Skills: Analytical and problem-solving skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully, react quickly to address urgent requests and meet challenging timelines Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills 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. 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 imagination 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.
