Job Title: Specialist Quality Assurance
Duration: 18 Months
Location: Easton, PA 18045 (Langham Logistics Warehouse – third-party GMP site)
 
Description:
ONSITE AT: Easton, Pennsylvania reporting daily. The candidate will physically work on-site at Langham Logistics, a third-party GMP-compliant warehouse in Pennsylvania.
Expected hours: 8:00 AM to 5:00 PM, Monday–Friday.

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:
• 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 company while interacting with representatives of regulatory agencies
• Demonstrated proficiency using Excel, Word, and PowerPoint
 
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. 

 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $37.00/hr.