Quality Assurance Specialist - Quality Systems - 3 OPENINGS
Amgen
8 days ago
Remote friendly (Holly Springs, NC)
United States
Operations
Quality Assurance Specialist - Quality Systems (3 openings)
What You Will Do
- Support and maintain Quality Systems including Deviations, CAPA, change control, document control, training, risk management, QA for QC, audits and inspections.
- Track implementation progress, monitor systems performance, and report status in governance forums.
- Alert senior management of quality, compliance, and safety risks.
- Provide guidance and training to employees on quality processes, procedures, and compliance expectations.
- Support continuous improvement initiatives related to quality processes, systems, and compliance performance.
- Act as site SME for Quality Systems; coordinate with global teams for alignment and best practices; ensure site effectiveness, efficiency, and compliance.
- Lead and/or participate in inspection readiness preparation and execution.
- Drive implementation of Quality Systems in compliance with Amgen Standards and Regulatory expectations.
Basic Qualifications
- High school diploma/GED and 10 years of Quality or Operations experience; OR
- Associate’s degree and 8 years; OR
- Bachelor’s degree and 4 years; OR
- Master’s degree and 2 years; OR
- Doctorate degree.
Preferred Qualifications
- Science educational background; broad cross-functional QA experience.
- Facilitating quality governance meetings; risk management knowledge.
- Understanding regulations/standards for Quality Management Systems.
- Strong organizational skills; ability to drive projects to completion.
- Monitoring performance and driving improvement; problem-solving.
- Strong stakeholder partnerships; decision-making in cross-functional teams.
- Experience with health authority inspections and partner/corporate audits.
- Excellent written and verbal communication.
Benefits (if eligible)
- Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending accounts; discretionary bonus; stock-based long-term incentives; time-off plans; flexible work models where possible.
Application Instructions
- Apply via careers.amgen.com; no application deadline (applications accepted until sufficient number/selection).
What You Will Do
- Support and maintain Quality Systems including Deviations, CAPA, change control, document control, training, risk management, QA for QC, audits and inspections.
- Track implementation progress, monitor systems performance, and report status in governance forums.
- Alert senior management of quality, compliance, and safety risks.
- Provide guidance and training to employees on quality processes, procedures, and compliance expectations.
- Support continuous improvement initiatives related to quality processes, systems, and compliance performance.
- Act as site SME for Quality Systems; coordinate with global teams for alignment and best practices; ensure site effectiveness, efficiency, and compliance.
- Lead and/or participate in inspection readiness preparation and execution.
- Drive implementation of Quality Systems in compliance with Amgen Standards and Regulatory expectations.
Basic Qualifications
- High school diploma/GED and 10 years of Quality or Operations experience; OR
- Associate’s degree and 8 years; OR
- Bachelor’s degree and 4 years; OR
- Master’s degree and 2 years; OR
- Doctorate degree.
Preferred Qualifications
- Science educational background; broad cross-functional QA experience.
- Facilitating quality governance meetings; risk management knowledge.
- Understanding regulations/standards for Quality Management Systems.
- Strong organizational skills; ability to drive projects to completion.
- Monitoring performance and driving improvement; problem-solving.
- Strong stakeholder partnerships; decision-making in cross-functional teams.
- Experience with health authority inspections and partner/corporate audits.
- Excellent written and verbal communication.
Benefits (if eligible)
- Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending accounts; discretionary bonus; stock-based long-term incentives; time-off plans; flexible work models where possible.
Application Instructions
- Apply via careers.amgen.com; no application deadline (applications accepted until sufficient number/selection).