Specialist Quality Control Support - Empower - Holly Springs, NC

Specialist Quality Control Support - Empower - Holly Springs, NC

Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please follow the next steps.

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared missionto serve patients living with serious illnessesdrives 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. Be part of Amgen's newest and most advanced drug substance manufacturing plant.

When completed, the Amgen FleX Batch facility will combine the latest in disposable 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 Amgen's plan to be a carbon-neutral company by 2027.

What You Will Do

In this pivotal role, you will support ANC Quality Control as the site's Business Process Owner (BPO) for Empower. Reporting directly to the Manager of Quality Control Support, you will serve as a subject matter expert for QC Empower based systems. Your expertise will help drive the startup, validation, and ongoing success of the QC Chemistry team utilizing the Empower based systems and enable manufacturing excellence. Because this role is tightly integrated with manufacturing operations, occasional extended hours, shift work, or weekend support for troubleshooting may be required. Working under minimal supervision, the successful candidate will contribute to both startup and daily operations of the QC organization by:

• System Leadership
• Leading QC Chemistry activities including Empower 3 FR5 qualification, validation, and upgrades.
• Managing the Empower BPO function, including troubleshooting, training, and participation in cross-functional meetings.
• Technical Expertise
• Supporting validation documentation for UPLC, HPLC, and CE computerized systems.
• Developing and executing Empower-based method transfer plans.
• Authoring, reviewing, and revising a wide range of documents: SOPs, test methods, safety assessments, trend reports, qualification/validation summaries, technical reports, and method/technical assessments.
• Operational Support
• Owning and managing Deviation or CAPA records to maintain compliance and quality standards.
• Continuous Improvement & Compliance
• Participating in audits, initiatives, and cross-functional or global projects.
• Driving process efficiency and ensuring alignment with quality and regulatory expectations.

Qualifications

What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The vital professional we seek is an effective leader with these qualifications. Basic Qualifications:

• High school diploma / GED and 10 years of Quality Analytical testing experience OR
• Associate's degree and 8 years of Quality Analytical testing experience OR
• Bachelor's degree and 4 years of Quality Analytical testing experience OR
• Master's degree and 2 years of Quality Analytical testing experience OR
• Doctorate degree

Preferred Qualifications:

• Experience working in a GMP Quality Control Chemistry Laboratory.
• Degree in Scientific Field such as Chemistry or Pharmaceutical Sciences or related scientific field.
• 4+ years of relevant laboratory experience in the GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred.
• Experience with Chemistry Quality Control testing, including but not limited to: HPLC, UPLC, Concentration and USP-NF methods.
• Strong Leadership, Collaboration and Communication skills.
• Strong knowledge of laboratory techniques.
• Proficient in the use of Empower, method templates, and sample sets in Empower.
• Knowledge of related regulatory/industry considerations, compliance issues, templating and/or scientific discovery.
• Strong written and verbal communication skills including technical writing and presentation.
• Experience with equipment and method validation, verification, and transfer including the change control process.
• Interact effectively with variety of communication and working styles and ability to work well in teams.

Location: Holly Springs, North Carolina

Job Code: Pharmaceutical Pharmaceutical

Company: Amgen

Salary Range: >$100,000