Associate Quality Control

JOB SUMMARY

The Associate Quality Control (QC) will support the QC General and Immunoassay team by performing testing using GC (Gas Chromatography), BLE (Breakloose and Extrusion), Moisture Determination by Karl Fisher, Osmolality, Solid Phase Extractions with UV Spectometer. In addition they will support ELISA methodologies testing for HCP (Host Cell Protein) and ProA (Protein A) Impurities, qPCR, Density and Reconstitution Time.

Key Responsibilities

Responsible for one or more of the following activities in QC: analytical testing, sample and data management and equipment maintenance.

Perform routine laboratory procedures such as sample analysis, standard and solution preparation.

Responsible for documenting, compiling, interpreting, reviewing and entering laboratory data.

Providing and communicating results, maintaining/operating specialized equipment and drafting and revising documents such as Analytical Methods, SOPs and technical reports.

Support introduction of new methods/techniques into the lab.

Perform basic assay and instrument troubleshooting.

Basic Qualifications

Bachelors degree

OR

Associates degree and 4 years of Quality experience

Or

High school diploma / GED and 6 years of Quality experience

Preferred Qualification

Experience in Immunoassay and qPCR techniques

Ability to adhere to regulatory requirements, written procedures and safety guidelines

Ability to evaluate documentation/data according to company and regulatory guidelines

Ability to organize work, handle multiple priorities and meet deadlines

Strong written and oral communication skills

Detail orientated

Flexible and adaptable to changing priorities and requirements

Demonstrate understanding of regulatory requirements, safety guidelines and factors impacting compliance

Demonstrates understanding of when and how to appropriately escalate

May identify, recommend and implement improvements related to routine job functions

Ability to learn and follow safety guideline and cGMPs

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 peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.

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.