Amgen UK is seeking a Quality Assurance Specialist for its manufacturing support team in the U.S. This role focuses on ensuring compliance with quality standards and regulations within the drug substance manufacturing process, offering the opportunity to make a significant impact on patient care
Job Summary
This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations.
Responsible for providing Quality oversight to ensure that Operations’ products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
Matching Summary
Match Score: 85
Amgen UK is seeking a Quality Assurance Specialist for its manufacturing support team in the U.S. This role focuses on ensuring compliance with quality standards and regulations within the drug substance manufacturing process, offering the opportunity to make a significant impact on patient care.
Salary
Base: 104,287.35USD - 141,094.65USD; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
cGMP compliance
Good Documentation Practices
Deviation investigation
Change Control assessment
CAPA management
Nice-to-have
Collaborative partnerships
Continuous improvement
Audit and inspection support
Key Requirements
High school diploma / GED and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience
Associate’s degree and 8 years of Quality, Manufacturing, Process Development or Process Engineering experience
Bachelor’s degree and 4 years of Quality, Manufacturing, Process Development or Process Engineering experience
Master’s degree and 2 years of Quality, Manufacturing, Process Development or Process Engineering experience