QC Associate

Location: West Greenwich

** 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.

** QC for Manufacturing - Team B Associate Quality Control*
* ** What you will do*
* Let's do this. Let's change the world. In this vital role you will be responsible for activities including microbiology & analytical testing, sample and data management and equipment and instrumentation operation and maintenance in a highly dynamic, team environment.

This role is expected to work a 10-hour shift Saturday - Tuesday, from 6:45AM-5:15PM.

Responsibilities include:

+ Perform sample collection and sample handling to support GMP operations and Environmental/Water monitoring within Manufacturing and Utility areas.

+ Perform testing and possible data review for compendia, non-compendia methods, and routine laboratory procedures. This includes bioburden, endotoxin, TOC, conductivity, and MMV testing along with additional daily microbiological testing.

+ Use of testing and data review within automated sampling systems, such as LIMS, LMES, and CIMS.

+ Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks.

+ Operate and maintain specialized laboratory equipment and instrumentation.

+ Participate in laboratory investigations and audits as necessary.

+ Perform general laboratory housekeeping activities.

+ Maintain training compliance and proficiency.

+ At all times, comply with safety guidelines, cGMPs and other applicable regulatory requirements.

** 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 a good teammate with these qualifications.

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* Basic Qualifications:

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* + High school/GED + 2 years Quality experience OR​

+ Associate's + 6 months Quality experience OR​

+ Bachelor's​Bachelor's​

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* Preferred Qualifications:

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* + Professional work experience in a fast-paced, flexible GxP laboratory

+ Experience in a regulated biotechnology/pharmaceutical lab environment

+ Experience executing test methods for microbiology, i.e. bioburden and endotoxin testing.

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Experience with gowning and sampling within clean room areas.

+ Operation, maintenance experience with laboratory equipment.

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Demonstrated proficiency with electronic systems (LIMS, LMES, Trackwise, etc.).

+ Exposure to Operational Excellence initiatives including Lean Manufacturing and 5S.

+ Demonstrated written and oral communication skills, project management and presentation skills, and proven ability to manage priorities effectively.

+ Demonstrated ability to be flexible and adaptable to support business needs.

** What you can expect of us*
* As we work to develop treatments that take care of others, we also work to care…