Quality Assurance Specialist Job at Katalyst HealthCares and Life Sciences, Boston, MA

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  • Katalyst HealthCares and Life Sciences
  • Boston, MA

Job Description

Responsibilities:
  • Quality Assurance: Assist in the implementation and maintenance of quality assurance programs for cell therapy manufacturing activities.
  • Batch Record Review: Review and analyze batch records for adherence to Good Manufacturing Practices (GMP) and internal quality standards.
  • CAPA Implementation: Contribute to Corrective and Preventive Action (CAPA) initiatives, ensuring timely and effective resolution of quality issues.
  • Compliance Monitoring: Collaborate with cross-functional teams to monitor compliance with regulatory requirements and company policies.
  • Documentation: Maintain accurate and detailed documentation related to quality assurance activities.
Requirements:
  • Educational Background: Bachelor's degree in biology, life sciences, or a related field.
  • Prior internship experience in quality assurance within the biotechnology or pharmaceutical industry is highly desirable.
  • Familiarity with Good Manufacturing Practices (GMP) and their application in the biotech sector.
  • Familiarity with batch records and their significance in maintaining product quality.
  • Knowledge of Corrective and Preventive Action (CAPA) processes.
  • ttention to Detail: Strong attention to detail and commitment to maintaining high-quality standards.
  • Communication Skills: Effective communication skills, both written and verbal.

Job Tags

Internship,

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