Associate Quality Control - Nights Job West Greenwich Rhode Island USA,Quality Assurance

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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity‑related conditions.

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.

Associate Quality Control - Nights

What you will do

Let’s do this. Let’s change the world. In this vital role you will provide testing support for the QC Night Shift “Team D”(Tuesday-Friday from 10 PM – 8 AM) at Amgen Rhode Island.
This person will be responsible for working in the Quality analytical laboratory, using GMPs and GDPs to execute analytical testing. The ideal candidate enjoys tackling challenges and excels at time management with attention to detail.

Responsibilities will include, but are not limited to:

Performing analytical testing including time sensitive samples from Manufacturing (Titer/ MMV/ Mycoplasma/ Endotoxin/ Bioburden/ TOC/ Conductivity), Centralized Raw Material testing (compendial testing & microbiology), Environmental Monitoring and Critical Utilities, Sample Receipt and Aliquot.
Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with safety guidelines, cGMP (Good Manufacturing Practices) practices and other applicable regulations
Generates complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks
Operates laboratory equipment and instrumentation
Performs review and approval of assays, documents and records
Supports troubleshooting and problem solving
Alerts management of quality, compliance, supply and safety risks
Supports TRAs and deviations, as applicable
Completes required assigned training to permit execution of required tasks
Performs additional duties as specified by management

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is detail oriented with these qualifications.

Basic Qualifications:

High school diploma / GED and 2 years of Quality experience OR
Associate’s degree and 6 months of Quality experience OR
Bachelor’s degree

Preferred Qualifications:

1-3 years of experience in GMP analytical laboratory
Experience executing analytical /biological testing per Methods and/or Compendia
Experience with QC analytical systems and/or Quality systems
Self‑motivated, strong organizational skills and ability to manage multiple tasks at one time with minimal supervision
Strong communication skills (both written and verbal)
Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories.
Understanding of biopharmaceuticals process and related unit operations
Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy
Independent, self‑motivated, organized, able to…