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Allentown, Pennsylvania, United States
Onsite
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. 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 Quality Assurance
Location
Easton, Pennsylvania - ON-SITE
What you will do
Let’s do this! Let’s 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
Master’s degree and 2 years of quality assurance experience OR
Bachelor’s degree and 4 years of quality assurance experience OR
Associate’s 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 Amgen’s 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, 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. 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