Biologics Quality Assurance Specialist
hace 4 semanas
Quality Assurance Specialist - Biologics
Job Description:
We are seeking a Quality Assurance Specialist - Biologics to oversee and execute product release activities in compliance with regulatory requirements and global standards.
This person will provide QA oversight for sterile manufacturing operations, including aseptic processing, sterilization processes, and environmental monitoring.
Key Responsibilities:
Release Activities:
Execute product release activities in compliance with regulatory requirements and company standards
Sterile Production:
Provide QA oversight for sterile manufacturing operations, including aseptic processing, sterilization processes, and environmental monitoring
Documentation Management:
Manage and review quality documentation, including batch records, standard operating procedures (SOPs), validation protocols, and reports
Data Integrity:
Implement and maintain data integrity controls to ensure the accuracy, completeness, and reliability of quality data
Regulatory Compliance:
Stay abreast of regulatory requirements and industry best practices related to quality assurance
Quality Systems:
Contribute to the development, implementation, and maintenance of robust quality systems, including deviation management, change control, CAPA, and risk management processes.
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