Quality Assurance Specialist Job at Amgen (West Greenwich)

Quality Assurance Specialist

Amgen

Location:
United States , West Greenwich

Category:
Quality Control

Contract Type:
Not provided

Salary:

113191.00 - 131832.00 USD / Year

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Job Description:

The Quality Assurance (QA) Technical Services Specialist is a critical role for the ARI site. The QA Technical Services team provides quality oversight for the execution of key processes such as deviations, corrective actions, and change controls; as well as general quality partner support for functions outside of manufacturing (including PD, IS, and QC). Because the function is engaged with complex investigations and delivery of site strategic priorities, the role offers the opportunity to engage broadly across the ARI site and within the network. QA Specialists may be cross trained and/or assigned additional project specific duties, including continuous improvement initiatives, therefore, the ideal candidate will have demonstrated competencies across a broad range of quality-related disciplines. This role demands a proactive and autonomous professional, capable of making risk-based decisions to uphold and improve our quality management system.

Job Responsibility:

Provide quality advice and oversight to ensure products are manufactured, tested, stored, and distributed according to current good manufacturing procedures
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 change control process, ensuring changes and implementation strategies are thoroughly evaluated for impact to quality
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
Ownership and subject matter expertise of quality processes including Deviation, CAPA, EV, Change Control and Quality Risk Management
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

Requirements:

High school diploma / GED & 10 years of Quality and/or Manufacturing experience
Associate’s degree & 8 years of Quality and/or Manufacturing experience
Bachelor’s degree & 4 years of Quality and/or Manufacturing experience
Master’s degree & 2 years of Quality and/or Manufacturing experience
Doctorate degree
Demonstrated experience leading enterprise risk management within GxP environments
Experience supporting Product Reintroductions (PRIs) and New Product Introductions (NPIs)
Demonstrated abilities in problem solving, and experience managing deviation/change control/ CAPA
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

Nice to have:

Demonstrated experience leading enterprise risk management within GxP environments, including development of risk frameworks, predictive KPIs, escalation governance models, and cross-functional mitigation strategies
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

What we offer:

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

Additional Information:

Job Posted:
March 04, 2026

Employment Type:

Fulltime

Work Type:

Hybrid work

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