QC Associate

Position: QC Associate I
##
** Career Category
** Quality## ##
** Job Description**## 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. 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  part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations.

The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
** Associate Quality Control**##
** What you will do
** Let’s do this. Let’s change the world. In this vital role you will be performing testing within the Quality Control Microbiology laboratory. Responsibilities will include sampling and testing to support clean utilities qualification and establishment of the environmental monitoring program to deliver site start up and then transition to testing in support of Amgen North Carolina commercial product release. Scope includes in-process, release, stability and routine monitoring testing.

The Associate Quality Control, Environmental and Utilities Monitoring will report directly to the Manager of Microbiology.
* Support document review and authoring, including but not limited to: SOPs, safety assessments, methods, trend reports, microorganism assessments, and technical reports.
* Assist with execution of EMPQ activities to support establishment of environmental monitoring program.
* Perform routine environmental monitoring and utilities sampling.
* Perform routine quality control testing, including Bioburden, Endotoxin, conductivity and TOC.
* Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
* Participate in deviations, CAPAs, and cross functional investigations.
* Assist with general lab setup and 5S.
* Support routine activities over the weekends and public holidays as required.
* Assist with clean utilities performance qualifications, including water for injection, clean steam, clean compressed air, oxygen, and carbon dioxide distribution systems.
* Support routine activities over the weekends and public holidays as required.
* Perform routine tasks such as cleaning and inventory management.
** What we expect of you
** We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a quality control professional with these qualifications.
*
* Basic Qualifications:

*** High school/GED + 2 years of related GxP laboratory experience OR
* Associate’s + 6 months of related GxP laboratory experience OR
* Bachelor’s
*
* Preferred Qualifications:

*** Experience working in a GMP pharmaceutical production facility with classified areas and applicable gowning requirements.
* Degree in Microbiology, Biology, Biochemistry, or related scientific field.
* Experience with microbiological quality control testing, including but not limited to:
Endotoxin, Bioburden, Microbial Identification, TOC, PCR.
* Strong knowledge of aseptic technique.
* Experience with environmental monitoring and clean utilities monitoring.
* Proficient in Good Documentation Practices.
* Strong…