Associate Quality Control

JOB SUMMARY:

Shift: Saturday through Tuesday 7AM to 5PM

Under general supervision, this position will perform routine procedures and testing in support of the Microbiology, EM Utilities, PCR, TOC, Conductivity Testing group. This position will be responsible for one or more of the following activities: - Performing routine laboratory procedures - Routine analytical testing - Documenting, computing, compiling, interpreting and entering data - Maintaining and operating specialized equipment - Initiating and / or implementing changes in controlled documents. Must learn and comply with safety guidelines and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory log books. Skills: Lab experience is preferred. This position is for the following shift: Saturday through Tuesday 7AM to 5PM and is considered an essential position. Individual will be required to report to the site each workday.

• Perform sample collection and sample handling to support GMP operations and Environmental/Water monitoring
• Perform testing and possible data review for compendia, non-compendia methods, and routine laboratory procedures
• 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
• Complete training on assigned tasks
• Follow established procedures and requirements to execute assigned tasks
• Comply with Good Manufacturing Practices and Good Documentation Practices
• Comply with gowning and hygiene requirements defined for specific job role
• Report any condition that can impact product quality or safety to management
• Stop executing any assigned tasks in the event of safety or quality concerns
• Participate in quality improvement efforts

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:

• Professional work experience in a fast-paced, flexible GxP laboratory
• Experience executing test methods for microbiology and raw materials Operation, maintenance experience with laboratory equipment.
• 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
• Ability to be flexible and adaptable to support business needs

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.

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.