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Quality Assurance Specialist

Easton, PA 60015

Posted: 01/15/2026 Employment Type: Contract Job Category: Quality Job Number: 4834

Job Description

Our client is looking to add a Quality Assurance Specialist to their team on a contract basis. This role will be onsite in Easton, PA, and contract term is 18 months.

Responsibilities:
  • Ensure that all operations comply 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
  • Compile and review documentation associated with receipt, storage, incoming inspection, and distribution
  • Perform routine Quality Assurance assessments and provide direct operational oversight
  • Provide expert advice on quality matters to operational teams and cross-functional groups
  • Ensure staff complete necessary training related to Amgen business operations
  • Approve GMP processes, procedures, documents, and records, addressing deviations, CAPAs, change controls, risk assessments, and validation records as required
  • 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
  • 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
  • Perform additional duties as assigned by management

Requirements / Qualifications:
  • Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
  • 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 strategic 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


 
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About Easton, PA

Explore exciting job opportunities in the vibrant area surrounding Easton, Pennsylvania! This charming locale nestled in the Lehigh Valley offers a perfect blend of urban amenities and scenic beauty, making it a great place to live and work. With its bustling downtown area featuring the iconic Crayola Experience and State Theatre Center for the Arts, job seekers can enjoy a unique cultural scene. The region is also renowned for its diverse culinary offerings, including the famous Easton Farmers' Market and a thriving food truck scene. Embrace the local sports spirit by catching a game at the PPL Center, home to the Lehigh Valley Phantoms. Easton, PA also boasts an array of beautiful parks and outdoor recreation areas, providing the perfect balance between work and play. Take the next step in your career journey and discover the endless possibilities waiting for you in Easton and its surroundings. Explore our job listings today and embark on an exciting new chapter!