Senior Associate Quality Control Lead - Nights at Amigen

Holly Springs, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

09 May, 26

Salary

100822.0

Posted On

08 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Control, Analytical Testing, GMP Compliance, Data Integrity, Problem-Solving, Communication, Organizational Skills, Chemistry, Bioassay, Microbiology, LIMS, Continuous Improvement, Laboratory Investigations, Documentation, Team Leadership, Shift Operations

Industry

Biotechnology Research

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. 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. Senior Associate Quality Control Lead - Nights 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 lead for night shift support. Reporting directly to the Director of Quality Control, the Senior Associate, Quality Control I (Night Shift Lead) 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. 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. 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 Associate’s degree and 2 years of Quality, Analytical Testing, or GxP Computerized System validation experience OR Bachelor’s degree and 6 months of Quality, Analytical Testing, or GxP Computerized System validation experience OR Master’s degree Preferred Qualifications: 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. 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! careers.amgen.com 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 83,951.00 USD - 100,822.00 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, visit www.amgen.com and follow us on www.twitter.com/amgen

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Responsibilities

Lead night shift QC operations, ensuring accurate sample management and timely analytical testing. Serve as the primary QC point of contact for Manufacturing during night shift operations.