Quality Assurance Specialist (GMP/Non-IT)

Easton, Pennsylvania

SPECTRAFORCE
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Job Title: Specialist Quality Assurance

Duration: 18 Months

Location: Easton, PA 18045 (Langham Logistics Warehouse - third-party GMP site)

Expected hours: 8:00 AM to 5:00 PM, Monday-Friday.

The candidate will physically work on-site at Langham Logistics, a third-party GMP-compliant warehouse in Pennsylvania.


Description:

Responsibilities:

  • Ensure operations align with applicable regulations and client's 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 Client 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 client's 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:

  • The ideal candidate will have 5+ years of QA experience specifically involving raw materials in a GMP-regulated environment such as pharmaceutical, biotech, or other life sciences industries. A bachelor's degree is strongly preferred; master's candidates may be considered, but Ph.D.-level talent may be too senior for the scope.
  • 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. Serves as a role model for client's values.
  • 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 while interacting with representatives of regulatory agencies.
  • Demonstrated proficiency using Excel, Word, and PowerPoint.
Date Posted: 08 June 2025
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