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Senior Specialist, Quality Assurance
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Senior Specialist, Quality Assurance
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Quality Assurance Sr. Specialist
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Quality Assurance Senior Specialist
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Quality Assurance Senior Specialist
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Quality Assurance Senior Specialist
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Senior Quality Assurance Specialist
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Senior Quality Assurance Specialist
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Quality Assurance Specialist
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Quality Assurance Specialist
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Commercial GMP Quality Assurance Specialist
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Quality Assurance Specialist
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CT Quality Assurance Specialist
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Technical Specialist, HLA
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QA/QC Superintendent
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Sr. Director of Regulatory Affairs
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Regulatory Documentation Specialist
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Eliot Community Human Services Boston, United States$3000 Sign on Bonus · The new Flexible Support Services initiative is an innovative model of care that includes funding to address many barriers to long term sustainable housing and recovery. The successful candidate will have unwavering compassion, an open mind in terms of path ...
Quality Assurance Specialist - Boston, United States - Katalyst Healthcares and Life Sciences
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.