About the role
Career Category
QualityJob Description
QA Specialist, Deviations
Role Overview
The QA Specialist, Deviations provides Quality Assurance oversight and subject matter expertise for deviations, investigations, CAPAs, and change controls. Working closely with Manufacturing, Engineering, Validation, Quality Control, and Supply Chain, the role ensures quality investigations are managed effectively and in compliance with GMP requirements, regulatory expectations, and Amgen standards.
Key Responsibilities
- Provide QA oversight of deviations, investigations, CAPAs, and change controls, ensuring timely and compliant execution.
- Review and approve quality records, ensuring appropriate scope, root cause analysis, risk assessment, and corrective actions.
- Represent QA at Deviation Review Boards, Change Control Boards, and other cross-functional forums.
- Support complex investigations and provide quality guidance on compliance and operational issues.
- Monitor quality system trends and support continuous improvement initiatives.
- Contribute to Annual Product Reviews and quality metrics reporting, as required.
- Support internal audits, regulatory inspections, and inspection readiness activities.
- Perform all activities in compliance with Amgen safety standards and SOPs.
- Responsibilities may expand to include additional areas aligned with business needs.
Preferred Qualifications and Experience
- Bachelor's degree in Science, Engineering, Pharmacy, Biotechnology, or a related discipline.
- Minimum 5 years' experience in the pharmaceutical or biotechnology industry.
- Experience providing QA oversight of deviations, investigations, CAPAs, and change controls in a GMP environment.
- Strong understanding of GMP requirements, quality systems, and risk management principles.
- Strong analytical, problem-solving, communication, and stakeholder management skills.
- Ability to work independently and effectively in a cross-functional environment.
- Excellent organisational, communication, coordination, and meeting facilitation skills.
- Proven track record of supporting continuous improvement initiatives within a regulated environment.
Salary Range
67,813.85 EUR - 91,748.15 EURAplyr's read
Amgen is a biotechnology leader focused on innovative therapeutics in oncology, cardiovascular, and inflammation, attracting professionals in science, engineering, and data analytics.
What's promising
- •Strong focus on cutting-edge biotechnology and human therapeutics.
- •Diverse career opportunities in scientific, engineering, and data roles.
- •Commitment to addressing serious health conditions like cancer and cardiovascular disease.
What to watch
- •Highly competitive industry with constant innovation demands.
- •Regulatory challenges in developing and marketing new therapies.
- •Potential for high-pressure work environment due to ambitious goals.
Why Amgen
- •Pioneering in biologic therapies with a focus on serious diseases.
- •Robust pipeline of innovative drugs in various therapeutic areas.
- •Global presence with a strong emphasis on research and development.
Aplyr’s read is generated by AI from public sources. Was it useful?
About Amgen
Amgen is a leading biotechnology company that discovers, develops, manufactures, and delivers innovative human therapeutics. The company focuses on areas such as oncology, cardiovascular disease, and inflammation.
