Manager Quality Control I - Nights

Amgen SA; Holly Springs, Northern (NC, KY); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Competitive benefits

Retirement and Savings Plan

Medical, dental, and vision coverage

Flexible spending accounts

Job summary

Amgen is seeking a Manager, Quality Control I (Night Shift) to lead QC operations on a Wednesday–Saturday schedule in North Carolina. You will supervise night-shift testing, ensure GMP-compliant procedures, and maintain data integrity across chemistry, biology, and microbiology labs.

Reporting to Quality Control leadership, you will drive coordination with manufacturing, handle deviations, and mentor team members while supporting continuous improvement initiatives within a GMP environment.

Qualifications

• High school diploma / GED or higher with extensive QC experience.
• Multiple degree paths acceptable with progressive QC experience.
• Strong leadership experience managing people or projects while performing QC duties.

Responsibilities

• Provide operational leadership for QC night shift activities and entry of data into LIMS.
• Serve as primary QC point of contact for Manufacturing during night shift operations.
• Perform routine and complex analytical testing in chemistry, bioassay, and/or microbiology.
• Ensure documentation complies with GDP, GMP, and 21 CFR Part 11 requirements.
• Support investigations related to deviations or OOS results and escalate risks.
• Utilize LIMS, Biovia, and Veeva Vault systems in daily work.
• Collaborate cross-functionally to meet testing timelines and drive improvements.

Skills

Leadership

GMP compliance

Quality control

Analytical testing

LIMS usage

Education

High school diploma / GED

Associate's degree

Bachelor's degree

Master's degree

Doctorate degree

Tools

LIMS

Biovia (LES, ELN, CIMS/CISPro)

Veeva Vault (QualityDocs, QMS)

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-d 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 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.

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 OR
• Associate’s degree and 10 years of quality control experience OR
• Bachelor’s degree and 5 years of quality control experience OR
• Master’s 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:

• 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 Part 11 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.

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.