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Quality Assurance Specialist - Quality Systems - 3 OPENINGSAmgen • United States
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Quality Assurance Specialist - Quality Systems - 3 OPENINGS

Amgen
  • US
    United States
  • US
    United States
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Über

Quality Assurance Specialist - Quality Systems
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Let's do this. Let's change the world. In this vital role you will serve as a Quality Assurance Specialist responsible for specific systems within the QMS at ANC. This role provides an opportunity to collaborate with cross-functional stakeholders, the Amgen global network, and the site Quality Leadership Team, ensuring the effective implementation, maintenance, and continual improvement of the QMS. 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, and 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. We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a dynamic, flexible, and driven individual with these qualifications. High school diploma / GED and 10 years of Quality or Operations experience OR Associate's degree and 8 years of Quality or Operations experience OR Bachelor's degree and 4 years of Quality or Operations experience OR Master's degree and 2 years of Quality or Operations experience OR Doctorate degree Educational background in a science field. Broad QA background supporting cross-functional quality operations. Experience facilitating quality governance meetings. Knowledge of risk management methodologies. Understanding of regulations, standards and guidelines associated with Quality Management Systems. Strong organizational skills and demonstrated ability to drive projects to completion. Experience in monitoring performance and driving improvement. Demonstrated ability in problem solving. Capability to build strong and collaborative partnerships with stakeholders and partners and influence changes to ensure compliant, efficient, and effective operations. Experience working with dynamic cross-functional teams and proven abilities in decision making Experience participating in, managing, and/or responding to health authority inspections, partner and corporate audits. Excellent written and verbal communication skills. As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team.
  • United States

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  • English
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