Quality Assurance Specialist - Allentown PA

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
• 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

Minimum Education Required

High School/GED

Additional Qualifications/Responsibilities

• 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

Salary Range

$75,000-$100,000