Career CategoryQuality
Job DescriptionSpecialist Quality AssuranceLocationEaston, Pennsylvania - ON-SITE
What you will doLet'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 youWe 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 usAs 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.comIn 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.
Salary Range
104,287.35USD -141,094.65 USD
