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    Quality Assurance Specialist - Boston, United States - Katalyst Healthcares and Life Sciences

    Katalyst Healthcares and Life Sciences
    Katalyst Healthcares and Life Sciences Boston, United States

    3 weeks ago

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    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.


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