Specialist QA

Amgen; West Greenwich (RI); On-site; USD 104,000 - 141,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental and vision coverage

Stock-based incentives

Flexible work models

Job summary

Amgen seeks a Quality Assurance Specialist to safeguard GMP manufacturing, testing, storage, and distribution across the network. You will act as a SME for deviation, CAPA, change control and risk management, driving improvements and ensuring robust quality systems.

Qualified candidates bring extensive QA and manufacturing experience, strong documentation and cross-functional collaboration skills, and a proven ability to translate quality requirements into practical actions in a fast-paced

Qualifications

• High school diploma or GED with 10 years in Quality, Manufacturing, Process Development or Process Engineering.
• Associate’s degree with 8 years in Quality, Manufacturing, Process Development or Process Engineering.
• Bachelor’s degree with 4 years in Quality, Manufacturing, Process Development or Process Engineering.
• Master’s degree with 2 years in Quality, Manufacturing, Process Development or Process Engineering.
• Doctorate degree in a relevant field.

Responsibilities

• Provide quality oversight to ensure GMP-conformant manufacturing, testing, storage, and distribution.
• Serve as SME for Deviation, CAPA, Change Control and risk management processes.
• Develop and maintain understanding of applicable requirements and best practices.
• Offer risk-based quality advice for investigations, corrective actions, and change control.
• Review and approve GMP documents, records, and procedures; ensure inspection readiness.
• Collaborate with project teams to integrate quality into planning and execution.
• Independently assess and prioritize quality risks across functions.
• Drive continuous improvement initiatives across site and network.
• Maintain relationships within Amgen to benchmark and share best practices.

Skills

Quality

Manufacturing

Process Development

Process Engineering

CAPA

Deviation

Change Control

Risk management

Documentation

Communication

Education

High school diploma or GED

Associate’s degree

Bachelor’s degree

Master’s degree

Doctorate degree

Job description

Career Category Operations 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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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

What you will do

Key Responsibilities

• Provide quality advice and oversight to ensure products are manufactured, tested, stored, and distributed according to current good manufacturing procedures.
• Serve as the ARI Subject Matter Expert (SME) for Deviation, CAPA, Change Control and risk management processes, responsible for monitoring QMS process health and performance, driving continuous improvement initiatives, providing technical and procedural expertise, and leading or supporting strategic projects to enhance compliance, effectiveness, and operational efficiency.
• Develop and maintain a working understanding of applicable requirements and best practices.
• Leverage knowledge and experience to provide risk-based Quality advice on strategies for successful investigation of deviations; as well as implementation of corrective actions, and change control manage the quality processes, ensuring changes are thoroughly evaluated for impact to quality, and strategies for implementation follow Amgen’s processes and procedures.
• Perform review and approval of GMP processes, procedures, documents, and records, including deviations, corrective actions, change controls, effectiveness verifications, standard operating procedures, batch records, and protocols.
• Collaborate with project teams to integrate quality considerations and controls into project planning and execution.
• Independently assess and prioritize quality risks across various functions and processes.
• Implement proactive measures to prevent potential issues and ensure a state of inspection readiness.
• Maintain relationships within the Amgen network to help benchmark and share best practices.
• Drive continuous improvement initiatives at the site and network level to create value for the business.

Basic Qualifications

• High school diploma / GED & 10 years of Quality, Manufacturing, Process Development or Process Engineering experience
• Associate’s degree & 8 years of Quality, Manufacturing, Process Development or Process Engineering experience
• Bachelor’s degree & 4 years of Quality, Manufacturing, Process Development or Process Engineering experience
• Master’s degree & 2 years of Quality, Manufacturing, Process Development or Process Engineering experience
• Doctorate degree

Preferred Qualifications

• Deliver expert quality and technical support for the resolution of complex contamination control investigations and experience with environmental monitoring programs.
• Experience supporting Product Reintroductions (PRIs) and New Product Introductions (NPIs), ensuring robust quality system integration, supplier readiness, risk assessments, change control oversight, and seamless alignment with regulatory and inspection readiness expectations across global networks.
• Demonstrated ability in problem solving, and experience managing deviation/change control/ CAPA & risk management.
• Excellent written and verbal communication skills with cross functional teams, network, and management.
• Proven ability to make informed risk-based decisions to drive continuous improvement and maintain quality and compliance.
• Experience with Regulatory inspections.

What You Can Expect From Us

• 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.

Equal Opportunity Employer

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Salary

Salary Range 104,287.35USD -141,094.65 USD

Sponsorship

Sponsorship for this role is not guaranteed.

Application Deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen