Amgen Associate Quality Control, Cell Biology in Thousand Oaks, California
The Associate in the Cell biology group within Amgen's Quality Control organization will work in a dynamic team environment to support testing, and projects within the group. The position will be responsible for cell Biology lab activities including analytical testing and approving, tracking and trending of data, equipment qualification and maintenance, method validation and qualification, project management, provide technical expertise.
Execute routine and non-routine testing procedures and assays
Create and review methods and procedures for completeness and accuracy
Maintain testing equipment at a high level to quality to ensure accuracy and consistency of test results
Perform data analysis of testing results and communicate results to appropriate sources
Comply with safety guidelines
Learn and comply with Good Laboratory Practices (GLP), and Good Manufacturing Practices (cGMPs), which includes, but is not limited to, the maintenance of training records, laboratory notebooks, written procedures, equipment monitoring systems and laboratory log books
Responsible for documenting, computing, compiling, interpreting, reviewing, and entering data
Responsible for the inventory management of all media and reagents
Partner with subject-matter-experts and/or responsible for the design of special project studies
Ensure the timely disposal of tested samples
- Responsible for managing and performing and/or supporting method and equipment qualifications and validations
Associate's degree and 4 years of Operations or Quality experience
High school diploma / GED and 6 years of Operations or Quality experience
Bachelor's degree in Biological Sciences
3+ years' experience with mammalian cell culture and bioassay technology, analytical methods
3+ years' of biopharmaceutical and/or medical technology experience with increasing responsibility in the quality control or manufacturing organization and a track record of strong scientific contributions and project leadership
Demonstrated ability to independently identify, develop and implement scientific solutions to practical problems; ability to apply established platform approaches and utilize solid problem solving skills as well as out-of-the-box thinking to contribute to technology improvements
Demonstrated in-depth knowledge of laboratory equipment and operations
Demonstrated communication and scientific writing skills
Knowledge and experience working with Material Safety Data Sheets (MSDS) / hazardous compounds and chemicals
Knowledge and experience with data trending, metrics generation, authoring protocols/reports, and authoring Standard Operating Procedures (SOPs)
Experience working with internal and external inspectors, ability to meet expectations and requirements of internal and external customers
Ability to assimilate information and make timely decisions that impact the functional area
Attention and dedication to quality
Ability to work as a team player
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.
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.