Quality Assurance Specialist - Katalyst Healthcares & Life Sciences
Boston, MA 02108
About the Job
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.
- 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.
- Attention to Detail: Strong attention to detail and commitment to maintaining high-quality standards.
- Communication Skills: Effective communication skills, both written and verbal.
Source : Katalyst Healthcares & Life Sciences