Job Description
Join our team as a Specialist I, QA Compliance focused on plasma operations within the pharmaceutical industry. This role ensures adherence to quality assurance regulations and practices.
In this position, you will be responsible for providing essential quality assurance oversight for plasma-related activities in support of hyperimmune manufacturing. Your expertise in cGMP and regulatory requirements will be pivotal in leading inspection readiness and supporting audits. You will work collaboratively across teams to enhance product quality and patient safety.
Key Responsibilities:
• Oversee compliance of plasma sourcing and operations
• Conduct internal and regulatory audits
• Review and analyze compliance documents and records
• Generate metrics and quality trends for management
• Assist in preparing responses for regulatory agencies
Requirements:
• Bachelor's degree in Biological Science or related field
• 5+ years of experience in parenteral pharmaceutic...
In this position, you will be responsible for providing essential quality assurance oversight for plasma-related activities in support of hyperimmune manufacturing. Your expertise in cGMP and regulatory requirements will be pivotal in leading inspection readiness and supporting audits. You will work collaboratively across teams to enhance product quality and patient safety.
Key Responsibilities:
• Oversee compliance of plasma sourcing and operations
• Conduct internal and regulatory audits
• Review and analyze compliance documents and records
• Generate metrics and quality trends for management
• Assist in preparing responses for regulatory agencies
Requirements:
• Bachelor's degree in Biological Science or related field
• 5+ years of experience in parenteral pharmaceutic...
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