Specialist Quality Assurance at Amgen in Juncos, PR

SPECIALIST QUALITY ASSURANCE Location: US - Puerto Rico - Juncos · On Site CAREER CATEGORY Quality JOB DESCRIPTION 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. SPECIALIST QUALITY ASSURANCE What you will do     Let's do this. Let's change the world! In this vital role, you will serve as a Quality Assurance professional accountable for the review and approval of Change Controls, Validation documentation, Equipment and Facilities lifecycle documentation, Process Qualification (PQ), Process Performance Qualification (PPQ), Periodic Monitoring, Process Reviews, and Annual Product Reviews (APR), ensuring compliance with cGMP requirements while safeguarding product quality and patient safety through sound judgment, strong ownership, cross-functional collaboration, and effective risk management in a dynamic drug product manufacturing environment.    Specific responsibilities include but are not limited to:  • 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.    What we expect of you     We are all different! Yet, we all use our unique contributions to serve patients. The Specialist QA professional we seek is a Quality-driven professional with these qualifications.     Basic Qualifications:     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   Preferred Qualifications:  • 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. WHAT YOU CAN EXPECT OF US 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. 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 & 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. 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. CAREERS.AMGEN.COM In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. SPONSORSHIP Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .