Career CategoryOperations
Job DescriptionQuality Assurance Specialist Let's do this. Let's change the world. 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.
Key Responsibilities include:- 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.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a great teammate with these qualifications.
Basic Qualifications:- High school diploma / GED & 10 years of Quality and/or Manufacturing experience OR
- Associate's degree & 8 years of Quality and/or Manufacturing experience OR
- Bachelor's degree & 4 years of Quality and/or Manufacturing experience OR
- Master's degree & 2 years of Quality and/or Manufacturing experience OR
- Doctorate degree
Preferred Qualifications:- Demonstrated experience leading enterprise risk management within GxP environments, including development of risk frameworks, predictive KPIs, escalation governance models, and cross-functional mitigation strategies to proactively identify and reduce quality and supplier-related risks.
- 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 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.
What you can expect from usAs 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.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
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 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. 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.comIn 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.
Application deadlineAmgen 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.
SponsorshipSponsorship for this role is not guaranteed.
