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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 career.
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.
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Support document review and authoring, including but not limited to: SOPs, safety assessments, methods, trend reports, microorganism assessments, and technical reports.
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Assist with execution of EMPQ activities to support establishment of environmental monitoring program.
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Perform routine environmental monitoring and utilities sampling.
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Perform routine quality control testing, including Bioburden, Endotoxin, conductivity and TOC.
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Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
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Participate in deviations, CAPAs, and cross functional investigations.
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Assist with general lab setup and 5S.
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Support routine activities over the weekends and public holidays as required.
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Assist with clean utilities performance qualifications, including water for injection, clean steam, clean compressed air, oxygen, and carbon dioxide distribution systems.
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Support routine activities over the weekends and public holidays as required.
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Perform routine tasks such as cleaning and inventory management.
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:
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High school/GED + 2 years of related GxP laboratory work experience OR
- Associate’s + 6 months years of related GxP laboratory work experience OR
- Bachelor’s
Preferred Qualifications:
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Experience working in a GMP pharmaceutical production facility with classified areas and applicable gowning requirements.
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Degree in Microbiology, Biology, Biochemistry, or related scientific field.
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Experience with microbiological quality control testing, including but not limited to: Endotoxin, Bioburden, Microbial Identification, TOC, PCR.
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Strong knowledge of aseptic technique.
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Experience with environmental monitoring and clean utilities monitoring.
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Proficient in Good Documentation Practices.
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Strong written and verbal communication skills, including technical writing and technical presentations.
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Able to flexibly work independently with minimal supervision and collaboratively on group tasks.
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, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
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A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
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A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
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Stock-based long-term incentives
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Award-winning time-off plans
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Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Amgen anticipates accepting applications until May 8th ; however, we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.
Sponsorship for this role is not guaranteed.
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.
