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Amgen Sr Associate QA in West Greenwich, Rhode Island

The Raw Material Disposition Senior Associate will be responsible for disposition of raw materials, deviation management and quality oversight. This position provides the opportunity to work directly with Supply Chain, Shipping, External Supply and Procurement for the incoming raw materials. As a Sr. Associate you will also facilitate real-time decision-making regarding quality requirements and deviations.  This is a unique opportunity to foster a strong partnership and learning environment between Supply Chain/Warehouse, External Supply and Disposition Quality staff. The primary focus of this role will be to support the disposition of raw materials while providing purposeful presence and oversight to the Warehouse teams. Amgen’s Raw Material Disposition team provides coaching, guidance and oversight to Supply Chain, Warehouse, Procurement and our PQA Partners overseeing Manufacturing Operations. As a Sr. Associate you would be responsible for the following in regards to compliance and quality systems:

  • Responsible for providing Quality oversight to ensure that products are manufactured, tested, stored, and distributed according to current Good Manufacturing.

  • Ensures Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.

  • Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.

  • Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Nonconformance, Corrective Action/Preventative Actions (CAPA), Change Control records and validations, Raw Materials and Drug Substance documentation.

  • Author/review/approve quality documents, such as:  SOPs, FORMs, user requirements, risk assessments, and training materials.

  • Establishes and enables LEAN practices by driving operational improvement initiatives, programs and projects.

  • Oversees and provides guidance of the Raw Material Reject Cage.

  • Ensures that changes that could potentially impact product quality are assessed according to procedures.

  • Ensures that deviations from established procedures are investigated and documented per procedures.

  • Ensures that raw material batch packets and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.

  • Alerts senior management of quality, compliance, supply and safety risks.

  • Completes required assigned training to permit execution of required tasks.

Basic Qualifications

Master’s degree

OR

Bachelor’s degree and 2 years of Quality experience

OR

Associate’s degree and 6 years of Quality experience

OR

High school diploma / GED and 8 years of Quality experience

Preferred Qualifications

  • Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies

  • Previous QA oversight of manufacturing or raw material warehouse

  • Experience in Raw Material or External Supplier Quality

  • Experience in investigations, change controls, and CAPAs processes system knowledge

  • Experience and training in EDMQ, Trackwise, Maximo, LIMS

  • Experience in managing multiple, competing priorities in a fast-paced environment

  • Direct bulk drug substance and drug product experience

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

  • Ability to solve complex problems and make scientific risk-based decisions

  • Demonstrated proficiency using Excel, Word and Power Point

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

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