Manager Quality Control I Nights

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. 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 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.

NOTE: This is a Wednesday - Saturday schedule night shift.

Lets do this. Lets change the this vital role you will play a key role in the Quality Control teamas the Manager for night shift support. Reporting directly to the Director of Quality Control the Manager Quality Control I (Night Shift) is an experienced QC professional who provides independent technical execution and shift-level leadership within a GMP-regulated laboratory environment. This role is accountable for leading night shift QC operations ensuring accurate sample management timely analytical testing and sustained compliance with GMP data integrity and safety requirements.

• Provide operational leadership for QC night shift activities including sample receipt prioritization and accurate entry into LIMS.
• Serve as the primary QC point of contact for Manufacturing during night shift operations supporting production schedules issue resolution and risk escalation.
• Independently perform routine and complex 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.

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

Basic Qualifications:

• High school diploma / GED and 12 years of quality control experience OR
• Associates degree and 10 years of quality control experience OR
• Bachelors degree and 5 years of quality control experience OR
• Masters degree and 3 years of quality control experience OR
• Doctorate degree

In addition to meeting at least one of the above requirements you must have experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications:

• Bachelors degree in a scientific discipline or equivalent experience.
• Experience working in a GMP-regulated Quality Control laboratory with demonstrated ability to work independently.
• Prior experience serving as a shift lead point of contact or informal team lead within a QC laboratory.
• Hands-on analytical testing experience in chemistry bioassay and/or microbiology.
• Strong knowledge 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.

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.

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:

• 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
• A discretionary annual bonus program or for field sales representatives a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• 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 does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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.

Salary Range