Quality Assurance Specialist - Quality Systems - 3 OPENINGS

Amgen • Holly Springs, NC

1d • $104,287 - $141,095

About The Position

Join Amgen’s Mission of Serving Patients. 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.

Quality Assurance Specialist - Quality Systems (3 openings)

What you will do
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.

Requirements

• 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

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED