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Specialist, Quality Assurance

Easton, PA 18042

Posted: 06/13/2025 Employment Type: Contract Job Category: Quality Job Number: 4502

Job Description

Responsibilities:
  • Ensure operations align with applicable regulations and company requirements relating to Good Manufacturing Practices, Good Distribution Practices, Good Documentation Practices, and Safety
  • Collaborate with the LSP to ensure adherence to service levels, identifying performance improvement opportunities in alignment with the Operations READ framework (reliability, efficiency, agility, differentiation)
  • Implement business continuity for services and processes
  • Partner with key internal customer groups and/or outside vendors to ensure successful operations
  • Participate / Conduct quarterly Business / Quality reviews and address service failures with the LSP
  • Ensure metric targets are achieved and establish standardized mechanisms to measure progress against targets
  • Understand and incorporate risk management strategy into overall supply chain strategy
  • Ensure compliance with required training for staff supporting company business
  • Provide leadership, guidance, mentorship, and training to staff and partner groups
  • Perform receipt, storage, and distribution documentation review to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
  • Perform cGMP process, procedure, document and record review, and approval, including but not limited to deviations, CAPAs, change controls, risk assessment, and validation records
  • Perform incoming raw material inspection, environmental monitoring, and documentation review
  • Provide leadership updates regarding the health and initiatives relating to the QMS at site management reviews
Preferred Qualifications:
  • Ability to liaise/communicate effectively and easily with cross-functional teams and different cultures (excellent written and verbal communication skills)
  • Self-leadership and motivation
  • Strategic mindset
  • Understanding of industry requirements (GMP, GDP, Import/Export) Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies
  • Previous QA oversight of distribution, warehousing, incoming QA, manufacturing, validation, and facility and engineering activities
  • Experience in deviation, change controls, and CAPAs processes system knowledge
  • Ability to evaluate compliance issues and interact with regulatory inspectors
  • Experience and training in Veeva, SM LIMS, ERP
  • Experience in managing multiple, competing priorities in a fast-paced environment
  • Experience leading and/or managing teams
  • Direct drug substance and/or drug product experience
  • Ability to solve complex problems and make scientific risk-based decisions
  • Experience representing the company while interacting with representatives of regulatory agencies
  • Demonstrated proficiency using 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!