Quality Compliance Associate Director - Aseptic Processing

Responsibilities

• This is a full-time remote position
• Specific responsibilities include but are not limited to:
• Serve as a aseptic processing and contamination control subject matter expert for Quality Compliance, Manufacturing, and site teams.
• Support the contamination control program, including site engagement, network participation, metrics review, risk identification, and escalation of significant concerns.
• Contribute to the development, revision, and implementation of global aseptic processing and contamination control standards, procedures, technical guidance, and quality intelligence documents.
• Support periodic contamination control reviews, trend evaluations, and state-of-control assessments for in-scope sites, processes, and products.
• Provide technical input for environmental monitoring, bioburden control, endotoxin, microbial identification, disinfectant efficacy, cleaning and disinfection, gowning, aseptic practices, utilities, facilities, and laboratory controls.
• Partner with site Quality, Manufacturing, Engineering, and QC laboratories to promote consistent application of contamination control expectations.
• Provide technical review and recommendations for microbiology investigations, deviations, CAPAs, risk assessments, change controls, audit observations, and inspection commitments.
• Support evaluation and implementation of new or improved technologies, practices, and contamination control tools.
• Contribute to Global Aseptic Council activities, technical forums, communities of practice, and network alignment discussions.
• Support regulatory inspections, internal audits, health authority commitments, and inspection-readiness activities related to microbiology, contamination control, QC laboratories, and manufacturing controls.
• Provide technical input to audit responses, regulatory inspection responses, CAPA plans, and effectiveness checks.
• Review regulatory filings, responses, or technical documents for aseptic processing -related content, as assigned.
• Monitor relevant regulatory, compendial, and industry developments and help translate them into practical expectations for sites and functions.
• Lead or support cross-functional projects related to aseptic processes, contamination control, laboratory practices, inspection readiness, or quality improvement.
• What we expect of you
• We are all different, yet we all use our unique contributions to serve patients. The Quality Compliance Associate Director - Aseptic processing we seek is an experienced, collaborative subject matter expert with these qualifications.

Requirements

• Doctorate degree and 3 years of Quality, Microbiology, Manufacturing, or relevant regulated industry experience OR
• Master's degree and 7 years of Quality, Microbiology, Manufacturing, or relevant regulated industry experience OR
• Bachelor's degree and 9 years of Quality, Microbiology, Manufacturing, or relevant regulated industry experience
• Associate's degree and 12 years of Quality, Microbiology, Manufacturing, or relevant regulated industry experience OR
• High school diploma / GED and 14 years of Quality, Microbiology, Manufacturing, or relevant regulated industry experience
• In addition to meeting at least one of the above requirements, you must have a minimum of 3 years'

Benefits

Additional Information

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. Quality Compliance Associate Director - Aseptic Processing

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