Associate Quality Control

This 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 successful candidate 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.

Responsibilities include:

Testing

• 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 GLP, and cGMPs, which includes, but is not limited to, the maintenance of training records, laboratory notebooks, written procedures, equipment monitoring systems and laboratory log books.

Material/Data Management

• 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

Qualification/Validation

• Responsible for managing and performing and/or supporting method and equipment qualifications and validations

Basic Qualifications:

Bachelor's degree

OR

Associate's degree and 4 years of quality experience

OR

High school diploma / GED and 6 years of quality experience

Preferred Qualifications

• A Bachelor's or Master's degree in Biological Sciences or a related field

• 3 or more years' experience with mammalian cell culture and bioassay technology

• At least 3 years of biopharmaceutical and/or medical technology experience with increasing responsibility in the organization

• Experience in biotechnology or a related industry with 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.

• Ability to execute projects as part of a team or independently.

• Knowledge of Bioassay analytical methods

• Knowledge and experience working with hazardous compounds and chemicals

• Knowledge and experience with cGMP regulations, practices and requirements pertaining to the manufacturing and testing of biopharmaceuticals,

• Knowledge and experience with data trending, metrics generation, authoring protocols/reports, and authoring SOPs

• Experience working with internal and external inspectors

• Knowledge and experience using the MSDS

• Knowledge with processes involved in manufacturing and distribution, QA, QC, validation and process development

• Ability to evaluate documentation/ operations according to company procedures

• Knowledge of multiple QC testing processes

• Ability to make decisions in a timely and thoughtful manner, taking in consideration available information

• Ability to respond appropriately if a situation requires a different set of skills and work approaches

• Ability to meet expectations and requirements of internal and external customers

• Ability to assimilate information and make timely decisions that impact the functional area

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.