Lead QA Specialist

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


AP Biosciences is seeking an experienced individual to fulfill the role of Lead QA Specialist. The ideal candidate will have the ability to provide supervision to the Operations Team. If you meet all requirements and think you are the perfect fit for this role, please apply now!

Responsibilities:

  • Supervise a team of QA Specialists 
  • Oversee production activities and make appropriate relevant decisions
  • Responsible for the review and approval of Materials Management and Supply Chain
  • Work in collaboration with cross-functional teams
  • Serve as the Primary Department Lead to manage and oversee the Environmental Monitoring Program
  • Manage metric generation and reporting
  • Responsible for the revision, review, and approval of SOPS, protocols, reports, etc.
  • Disposition of controlled materials
  • Provide support during compliance inspections
  • Continuously evaluate and improve manufacturing control systems

Requirements:

  • Must have a Bachelor’s degree in a scientific discipline (preferably in physical science or chemistry)
  • Must have at least 7-10 years of progressive experience in a GMP environment
  • Minimum of 7 years of Quality Assurance experience in support of GMP production
  • Knowledge of GMPs and their application to pharmaceutical manufacturing
  • Knowledge of FDA guidance documents
  • Previous exposure to investigations and product complaints
  • Ability to interpret applicable standards and make appropriate decisions
  • Microbiology/ Environmental Monitoring background is preferred
  • Proficiency in Microsoft Office Suite
  • Previous experience in utilization of MRP systems is preferred
  • Must be able to manage multiple operations and project work while working in a fast-paced environment
  • Ability to stay abreast of trends and stay up to date on new information in the profession
  • Excellent organizational skills

Position ID: 38037