Manager Quality Control I - Nights

Amgen Inc. (IR); Holly Springs (NC); On-site; USD 114,000 - 154,000; Full time

Job summary

Amgen Inc. (IR) is seeking a Manager, Quality Control I (Night Shift) to lead the night QC team in a GMP-regulated laboratory. The role focuses on independent technical execution, shift leadership, and timely analytical testing across chemistry, bioassay, and microbiology.

You will ensure data integrity, GDP, GMP, and 21 CFR Part 11 compliance, while supporting investigations and cross-functional collaboration to meet production schedules and testing timelines.

Qualifications

• Must meet one of the listed education/experience combinations with leadership experience.
• Experience leading night-shift QC operations in a GMP environment.
• Strong knowledge of data integrity, GDP, GMP and Part 11.

Responsibilities

• Lead night shift QC operations, ensuring timely testing and sample management.
• Provide shift-level leadership and coordinate with Manufacturing on schedules.
• Document test results compliant with GDP, GMP, and 21 CFR Part 11.

Skills

Leadership

Quality control

Education

High school diploma / GED

Associate's degree

Bachelor's degree

Master's degree

Doctorate degree

Tools

LIMS

Biovia

Veeva Vault

Job description

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. 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.

MANAGER QUALITY CONTROL I – NIGHT SHIFT

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

What you will do

Let’s do this. Let’s change the world. In this vital role you will play a key role in the Quality Control team as 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 Part11 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.

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 person with these qualifications.

Basic Qualifications

• High school diploma / GED and 12 years of quality control experience
• Associate's degree and 10 years of quality control experience
• Bachelor's degree and 5 years of quality control experience
• Master's degree and 3 years of quality control experience
• 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

• Bachelor's 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 Part11 compliance.
• Familiarity with compendial methods (e.g., USP–NF).
• 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, 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: 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.

careers.amgen.com

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.

Application deadline

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

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

114,063.20USD -154,320.80 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visitwww.amgen.comand followwww.twitter.com/amgen