Associate Quality Control, Environmental and Utilities Monitoring

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgens newest and most advanced drug substance manufacturing plant. When completed the Amgen FleX Batch facility will combine the latest in disposable 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 Amgens plan to be a carbon-neutral company by 2027.

Associate Quality Control Environmental and Utilities Monitoring

What you will do

Lets do this. Lets 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 Quality Control Specialist 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 Microbial Identification PCR 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 motivated professional we seek is a quality control professional with these qualifications.

Basic Qualifications:

• High School diploma/GED and 2 years of related GxP laboratory experience OR
• Associates degree and 6 months of related GxP laboratory experience OR
• Bachelors degree

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 written and verbal communication skills including technical writing and technical presentations.
• Able to flexibly work independently with minimal supervision and collaboratively on group tasks.

What you can expect of us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

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 and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

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 disability status or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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