Quality Assurance Specialist

Career Category Quality Job Description Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Specialist Quality Assurance Location Easton, Pennsylvania - ON-SITE What you will do Lets do this! Lets change the world! This onsite position provides critical support for the Raw Material Center (RMC) warehouse, based in Easton, Pennsylvania. The RMC represents an advanced logistics solution designed to optimize the raw material network, serve additional manufacturing sites, and facilitate inventory pooling and bulk purchasing. RMC services encompass direct supplier receipt, incoming quality inspection and sampling, environmental monitoring, storage, and transportation. Responsibilities: Ensure that all operations align with relevant regulations and Amgen requirements, including Safety, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Documentation Practices Conduct sampling and inspection of incoming raw materials, assess documentation, and determine disposition Review documentation associated with receipt, storage, and distribution Approve GMP processes, procedures, documents, and records, addressing deviations, CAPAs, change controls, risk assessments, and validation records as required Perform routine Quality Assurance assessments and provide direct operational oversight Offer leadership, guidance, mentorship, and training to staff and partner organizations Manage oversight of logistic and transportation service providers Provide expert advice on quality matters to operational teams and cross-functional groups Ensure staff complete necessary training related to Amgen business operations Achieve established metric targets and develop standardized approaches for tracking progress Collaborate with Logistic Service Providers (LSPs) to maintain service levels and identify areas for performance enhancement Participate in quarterly business and quality reviews and address any service failures with LSPs Present updates on LSP Quality Management System health and initiatives at management reviews Represent the Quality Unit during audits and inspections, directly interacting with regulatory agencies Support internal and external audits and inspections as a member of the audit/inspection team Implement business continuity plans for services and processes Form strategic partnerships with internal customers and external vendors to ensure operational success Integrate risk management strategies into overall supply chain management Lead initiatives, programs, and projects targeting operational improvements Develop solutions that are comprehensive, practical, and align with functional goals Perform additional duties as assigned by management What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications. Basic Qualifications: Doctorate degree OR Masters degree and 2 years of quality assurance experience OR Bachelors degree and 4 years of quality assurance experience OR Associates degree and 8 years of quality assurance experience OR High school diploma / GED and 10 years of quality assurance experience Preferred Qualifications: Proven ability to communicate effectively with cross-functional teams and diverse cultures, both verbally and in writing Academic background in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies Prior experience overseeing QA in distribution, warehousing, manufacturing, validation, and engineering functions Expertise in managing deviations, change controls, and CAPAs Proficiency in Veeva, SM LIMS, and ERP systems Knowledge of industry standards (GMP, GDP, Import/Export) Commitment to exemplifying Amgens core values Demonstrated self-leadership and motivation Strong critical thinking skills Ability to evaluate compliance issues and engage with regulatory inspectors Experience managing multiple priorities within a dynamic environment Direct experience with drug substances and/or drug products Advanced problem-solving abilities and capacity for scientific, risk-based decision-making Track record of representing an organization during regulatory interactions High proficiency in Microsoft Excel, Word, and PowerPoint What you can expect from 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, well 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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. . Salary Range 104,287.35USD -141,094.65 USD 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