Specialist QA 1
Amgen Inc
Amgen seeks a Quality Assurance Specialist to oversee plant quality assurance for bulk drug substance manufacturing operations. The role involves ensuring compliance with cGMP and GDP regulations, reviewing critical quality documents, and partnering with manufacturing and operational teams to support real-time quality decisions.
Responsibilities
- Provide quality oversight to ensure products manufactured, tested, stored and distributed per cGMP and GDP
- Review and approve batch records, deviations, change controls, and corrective/preventative actions
- Author and review quality documents including SOPs, risk assessments, and validation protocols
- Investigate and document deviations from established procedures per regulatory requirements
- Represent plant quality assurance during regulatory inspections and audits
Requirements
- High school diploma/GED plus 10 years quality, manufacturing, or process experience
- Or associate's degree plus 8 years relevant experience
- Or bachelor's degree plus 4 years relevant experience
- Or master's degree plus 2 years relevant experience
- Knowledge of cGMP biotech manufacturing regulations and cell culture operations
- Experience with quality management systems, change control, and risk management
- Demonstrated ability in deviation investigation and root cause analysis
Vacancy posted 4 days ago
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