Specialist QC

Amgen • Holly Springs, NC

2d

About The Position

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. 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 single use 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. Specialist, Quality Control Microbiology What you will do Let’s do this. Let’s change the world. In this vital role, you will lead the Environmental Monitoring and Utilities Monitoring programs to support the drug substance manufacturing facilities. The Specialist, Quality Control Microbiology will report directly to the Senior Manager of Quality Control Microbiology. This role may have a limited number of direct reports.

Requirements

• High school diploma / GED and 10 years of Quality or Aseptic Manufacturing experience
• Associate’s degree and 8 years of Quality or Aseptic Manufacturing experience
• Bachelor’s degree and 4 years of Quality or Aseptic Manufacturing experience
• Master’s degree and 2 years of Quality or Aseptic Manufacturing experience

Nice To Haves

• Experience working in a GMP pharmaceutical production facility with classified areas and applicable gowning requirements.
• Degree in Microbiology, Biology, Biochemistry, or related scientific field.
• Experience with environmental monitoring and clean utilities monitoring, including execution of EMPQ and trending of EM/utilities data.
• Experience with microbiological quality control testing, including but not limited to: Endotoxin, Bioburden, Microbial Identification, TOC.
• Experience with regulatory inspections
• Strong knowledge of aseptic technique.
• Strong written and verbal communication skills, including technical writing and technical presentations.
• Able to flexibly work independently, as a project owner, collaboratively on group tasks, and as a trainer.

Responsibilities

• Provide site-level leadership and strategic ownership of the Environmental Monitoring (EM) and Utilities Monitoring programs, ensuring sustained compliance, data integrity, and a proactive state of control across manufacturing operations.
• Serve as the primary subject matter expert (SME) for environmental monitoring, utilities monitoring, and contamination control, providing expert guidance to site leadership, cross-functional partners, and global stakeholders.
• Establish, oversee, and continuously improve monitoring strategies, including data review, trend analysis, interpretation and presentation to support risk-based decision making.
• Author, review, and approve GMP documentation and technical deliverables, including SOPs, safety assessments, trend reports, qualification and validation summary reports, microorganism assessments, and other technical reports.
• Lead the planning and execution of Environmental Monitoring Performance Qualification (EMPQ) activities in support of facility changes, expansions, and new initiatives, partnering closely with QC Micro Sampling and Testing teams.
• Provide technical oversight and governance for Clean Utilities qualification activities, ensuring alignment with regulatory expectations and internal quality standards.
• Drive cross-functional alignment with Manufacturing, Facilities & Engineering, Quality, and other stakeholders to ensure monitoring programs support both compliance and business objectives.
• Drive the site Contamination Control Strategy, participating in contamination risk assessments and ensuring effective implementation, monitoring, and continuous improvement in alignment with global standards.
• Represent the site in global environmental monitoring and contamination control forums, influencing best practices, sharing expertise, and driving harmonization across the network.
• Deliver clear, data-driven communication to site leadership, including routine presentations on environmental and utilities monitoring performance, risks, trends, and mitigation strategies.
• Lead and support regulatory inspections, internal audits, and cross-functional initiatives of site or global scope, serving as a technical authority during audits and inspections.
• Support QC Microbiology laboratory investigations and deviation investigations, ensuring timely resolution, robust root cause analysis, and sustainable corrective and preventive actions.
• Provide operational leadership and escalation support for routine monitoring activities, including coverage during weekends and public holidays as required to maintain compliance and operational readiness. This may include scheduling and coordinating routine or qualification activities with manufacturing operations

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED