Specialist Quality Assurance

Amgen • Juncos, PR

9d

About The Position

Join Amgen’s Mission of Serving Patients 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.

Requirements

• Doctorate degree OR Master’s degree and 2 years of Quality Assurance experience OR Bachelor’s degree and 4 years of Quality Assurance experience OR Associate’s degree and 8 years of Quality Assurance experience OR High school diploma / GED and 10 years of Quality Assurance experience

Nice To Haves

• Life Science and/or Engineering academic degree.
• Advanced experience in Quality Systems, with demonstrated expertise in Change Control, Validation, Equipment and Facilities Lifecycle Management, Process Qualification (PQ), Process Performance Qualification (PPQ), and associated Quality documentation within a regulated GxP environment.
• Strong independent decision-making skills with the ability to influence others and drive alignment across teams.
• Proven experience supporting regulatory inspections and audits, including demonstrated ability to interact with regulatory agencies and contribute to successful inspection outcomes.
• Proven ability to evaluate quality and compliance risks through risk-based decision making and drive cross-functional alignment to achieve compliant outcomes.
• Experience supporting drug product operations in a GMP-regulated environment.
• Proficient technical writing skills with the ability to produce concise, objective, evidence-based, inspection-ready documentation in compliance with ALCOA+ and Good Documentation Practices.
• Strong sense of accountability and ownership, with the ability to manage multiple high-impact Quality System deliverables simultaneously and deliver timely, compliant outcomes.
• Demonstrated ability to evaluate compliance issues, perform advanced data trending and analysis, and assess systemic quality risks.
• Ability to identify systemic quality signals, recurring process issues, and cross-functional process vulnerabilities through trend analysis, lifecycle monitoring, and prior event assessment.
• Experience supporting Change Controls, Validation activities, Equipment and Facilities Lifecycle Management, Process Qualification (PQ), Process Performance Qualification (PPQ), Periodic Monitoring, Process Reviews, and Annual Product Reviews (APR).
• Technically savvy and adaptable, with openness to leveraging digital tools, automation, and emerging technologies (including AI-enabled tools) to improve Quality System effectiveness.
• Flexibility to support variable schedules and cross-time-zone interactions, while consistently demonstrating Amgen Values and Leadership Practices.

Responsibilities

• Serve as the Quality approver for Change Controls, ensuring proposed changes are appropriately assessed, documented, implemented, and closed in accordance with Quality System requirements.
• Review and approve validation lifecycle documentation, including protocols, reports, risk assessments, and associated records for equipment, facilities, utilities, manufacturing processes, and computerized systems, as applicable.
• Review and approve Process Qualification (PQ), Process Performance Qualification (PPQ), Periodic Monitoring, Process Reviews, and Annual Product Reviews (APR), ensuring compliance with applicable procedures and regulatory requirements.
• Review, approve, and track cGMP documentation, including Change Controls, validation documentation, procedures, Work Orders, and associated quality records.
• Demonstrate strong critical thinking skills and apply risk-based decision making to evaluate quality impact and ensure compliance with cGMP requirements.
• Ensure quality records are complete, accurate, and compliant with Good Documentation Practices, ALCOA+ principles, and established Quality System requirements.
• Collaborate cross-functionally with Manufacturing, Engineering, Facilities, Validation, Maintenance, Technical Services, Regulatory, and Quality organizations to support timely execution of quality deliverables.
• Provide Quality guidance during implementation of equipment, facility, utility, process, and system changes to ensure compliance with applicable procedures and regulatory expectations.
• Escalate and communicate quality, compliance, supply, and patient safety risks to management, as appropriate.
• Support internal audits, regulatory inspections, and management review activities by providing Quality documentation and defending Quality decisions related to assigned Quality Systems.
• Support Continuous Improvement initiatives, leveraging process performance, validation lifecycle data, and quality trends to strengthen Quality Systems and improve compliance.
• Complete required training and perform additional duties as assigned by management.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• 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: No Education Listed