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Amgen Specialist Quality Assurance in Rhode Island, Rhode Island

Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that these molecules become medicines. Many of the technologies we’re employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping oncology patients.

Responsible for proving quality oversight functions related to the manufacture of Bulk Drug Substance at Amgen Rhode Island.

Responsibilities:

  • Leading and project managing complex investigations for major and critical deviation events associated with Amgen’s manufactured products, raw materials, Quality Control systems and processes, including manufacturing investigations.

  • Providing Quality oversight of Quality Control's minor Deviations, CAPA and EV records.

  • Providing Quality oversight on the day to day supply and management of raw materials, packaging and components.

  • Leading and project managing Change Control records for analytical method revisions, equipment installation and validation.

  • Responsible for Quality and/or Validation Assessor for Change Controls.

  • Supporting QC Equipment Life Cycle Management Program, including defining user requirements, procurement, installation and validation activities.

  • Supports inspection readiness activities across Quality Control, and site audits and inspections

Basic Qualifications:

  • Doctorate degree

  • OR

  • Master’s degree and 3 years of Quality experience

  • OR

  • Bachelor’s degree and 5 years of Quality experience

  • OR

  • Associate’s degree and 10 years of Quality experience

  • OR

  • High school diploma / GED and 12 years of Quality experience

Preferred Qualifications :

  • Previous experience in Quality Systems (Investigations, CAPAs, EVs, Change Controls)

  • Validation experience (Lab equipment, computer related systems)

  • Project management

  • Proficiency in Excel, Word, and PowerPoint

  • Strong interpersonal skills

  • Excellent written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff

We understand that to successfully sustain and grow as a global enterprise and deliver for patients — we must ensure a diverse and inclusive work environment.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

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 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.

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