Quality Assurance Specialist
About The Position
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.
Requirements
- 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
Nice To Haves
- 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
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
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
