Quality Assurance Specialist

Practice Area bioscience
Job Family Quality Assurance
Job Type Contract To Perm
Location Greater Boston


Do you have impressive communication skills? Are you proficient in Microsoft Office and able to manage day to day operations in a fast-paced environment? If so, this Quality Assurance Specialist Position is perfect for you! Submit your resume to apply today.

Responsibilities:

  • Oversee production activities such as clearance, issuance and batch record review, and discrepancy initiations
  • Maintain, revise, and confirm activities for Materials Management and Supply Chain
  • Assist Chelsea facility with their Environmental Monitoring Program
  • Revise and continuously improve SOPs, Protocols, Reports, and Master Batch Records
  • Introduce Discrepancies such as Deviations and Investigations
  • Assist with the implementation of CAPA regarding the Discrepancies Review and Certificate of Raw Materials, Intermediates, and Finished Goods approvals
  • Dispose of controlled materials
  • Assist with GMP manufacturing shifts as necessary

Requirements:

  • Bachelor’s in a scientific discipline, physical Science or Chemistry preferred
  • 3 or more years of progressive experience within GMP environment
  • At least 1 year of QA experience relating to GMP production
  • Complete understanding of GMPs and their relation to pharmaceutical manufacturing
  • Interpret standards and make decisions with managerial support 

Position ID: 37906