Senior Associate Quality Control Nights

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 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 Amgens plan to be a carbon-neutral company by 2027.

Senior Associate Quality Control - Nights

What you will do

Lets do this. Lets change the this vital role you will play a key role in the Quality Control team as the Senior Associate QC night shift support. Reporting directly to the Director of Quality Control the Senior Associate Quality Control I (Night Shift) is an expert QC professional who provides independent technical execution within a GMP-regulated laboratory environment. This role is accountable for operational testing and sample support on the QC night shift operations team ensuring sustained compliance with GMP data integrity and safety requirements.

• Execute QC night shift activities working with the night shift team lead including sample receipt prioritization and accurate entry into LIMS.
• Serve as a point of contact for Manufacturing during night shift operations supporting production schedules issue resolution and risk escalation.
• Independently perform routine and sophisticated analytical testing in chemistry bioassay and/or microbiology including STAT testing as required.
• Ensure accurate compliant documentation in accordance with GDP GMP and 21 CFR Part 11 requirements.
• Support laboratory investigations related to deviations or OOS results and communicate shift-level risks to QC leadership.
• Utilize electronic systems including LIMS Biovia (LES ELN CIMS/CISPro) and Veeva Vault (QualityDocs QMS).
• Collaborate cross-functionally to meet testing timelines and contribute to continuous improvement initiatives.
• Bachelors degree in a scientific discipline or equivalent experience.
• Experience working in a GMP-regulated Quality Control laboratory with proven ability to work independently.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The quality professional we seek is a strong great teammate with these qualifications.

Basic Qualifications:

• High school diploma / GED and 4 years of Quality Analytical Testing or GxP Computerized System validation experience OR
• Associates degree and 2 years of Quality Analytical Testing or GxP Computerized System validation experience OR
• Bachelors degree and 6 months of Quality Analytical Testing or GxP Computerized System validation experience OR
• Masters degree

Preferred Qualifications:

• Prior experience with hands-on analytical testing experience in chemistry bioassay and/or microbiology.
• Solid understanding of data integrity GDP GMP and 21 CFR Part 11 compliance.
• Familiarity with compendial methods (e.g. USPNF).
• Excellent communication and organizational skills with the ability to manage multiple priorities in a fast-paced manufacturing environment.
• High attention to detail strong problem-solving skills and ability to work autonomously during off-shift hours.

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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