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Quality Assurance (QA) Specialist

Quality Assurance (QA) Specialist

Katalyst Healthcares and Life SciencesBoston, MA, United States
6 days ago
Job type
  • Full-time
Job description

Responsibilities :

  • Monitor compliance with GMP, FDA, and regulatory requirements throughout manufacturing.
  • Conduct inspections, audits, and testing to ensure products meet quality standards.
  • Review batch records, documentation, and processes for compliance with quality protocols.
  • Investigate deviations, non-conformances, and customer complaints, implementing corrective actions.
  • ssist with the preparation for regulatory audits and inspections.
  • Support the development and maintenance of quality assurance systems and procedures.
  • Collaborate with cross-functional teams to resolve quality issues and improve processes.
  • Review and update Standard Operating Procedures (SOPs), batch records, and documentation.
  • Train staff on GMP guidelines and company quality policies.

Requirements :

  • Bachelor's degree in Pharmaceutical Sciences, Life Sciences, Chemistry, or a related field.
  • 2+ years of experience in Quality Assurance, preferably in the pharmaceutical or biotechnology industry.
  • Strong understanding of GMP, FDA regulations, and industry standards.
  • Experience with pharmaceutical manufacturing processes and quality control testing.
  • Strong attention to detail and communication skills.
  • Proficiency with Microsoft Office Suite; experience with quality management software is a plus.