Specialist QA

Amgen • Juncos, PR

1d

About The Position

The Specialist QA is an individual contributor who leads and supports Quality Risk Management (QRM) and Change Control Quality System activities across GxP-regulated operations. The role enables proactive, science-based decisions that protect patient safety, product quality, regulatory compliance, and business continuity.

The position facilitates risk assessments, evaluates and documents risks, integrates QRM into related quality processes, and maintains QRM governance, documentation, procedures, training, and performance metrics. It also manages the GxP change control lifecycle from initiation through closure, overseeing risk assessments, approvals, implementation evidence, and effectiveness verification. The Specialist drives continuous improvement and supports audit and regulatory inspection readiness.

Requirements

• Doctorate degree; or a master's degree and 2 years of Quality Assurance or Manufacturing support experience; or a bachelor's degree and 4 years of such experience; or an associate's degree and 8 years of such experience; or a high school diploma/GED and 10 years of such experience.

Nice To Haves

• Experience implementing Quality Risk Management programs in a GxP-regulated biopharmaceutical, pharmaceutical, medical device, or manufacturing environment.
• Strong knowledge of cGMP requirements and risk management standards, including ICH Q9, ICH Q10, and ISO 14971.
• Experience facilitating and documenting risk assessments using FMEA, HACCP, PrHA, and other risk-based decision-making methodologies.
• Working knowledge of Quality Systems and their integration with deviations, CAPA, investigations, change control, management review, and continuous improvement processes.
• Strong analytical, communication, and technical writing skills, with the ability to influence cross-functional stakeholders and support audit and inspection readiness.
• Experience leading the GxP change control lifecycle, including change definition and classification, risk and impact assessment, implementation planning, approval, effectiveness verification, and closure.
• Proficiency with an electronic Quality Management System such as CCMS, TrackWise, or an equivalent platform, including workflow management, audit trails, reporting, and maintaining accurate, inspection-ready records in accordance with data-integrity principles.

Responsibilities

• Facilitate and support risk assessments using established methodologies such as FMEA, HACCP, and Preliminary Hazard Analysis (PrHA).
• Evaluate and document risks affecting patient safety, product quality, compliance, and supply continuity.
• Partner with cross-functional teams to integrate QRM principles into deviations, CAPAs, investigations, and change controls.
• Maintain QRM governance processes, risk management documentation, procedures, training programs, and performance metrics.
• Analyze risk data and trends to support risk-based decision making.
• Manage the GxP change control lifecycle from initiation through timely closure, including classification, risk assessment, approvals, implementation, and effectiveness verification.
• Oversee qualification, validation, documentation, training, regulatory assessments, and evidence required for implementation and closure.
• Drive continuous improvement across QRM and Change Control using performance trends, lessons learned, and human-performance principles.
• Support inspection readiness for QRM and Change Control by maintaining retrievable evidence, presenting program governance and performance, and coordinating audit and regulatory inspection follow-up actions.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, and life and disability insurance.
• Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
• Stock-based long-term incentives.
• Award-winning time-off plans and an annual site shutdown.
• Flexible work models where possible.
• Work/life balance and career development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed