Specialist Quality Assurance - Environmental Control Program

Career CategoryQualityJob DescriptionJoin 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.Specialist Quality Assurance – Environmental Control ProgramMultiple positions availableWhat you will do   Let’s do this. Let’s change the world! In this vital role, you will provide expert technical support, quality leadership, and compliance guidance for the timely resolution and effective management of routine and non-routine Environmental Monitoring (EM) and Contamination Control matters across AML. This includes continuous oversight of EM programs for manufacturing classified areas, critical utility systems, and site GMP and non-GMP operational areas.As a Subject Matter Expert (SME) within the site Quality Operations team, this role provides technical advice and direction for complex operational deviations with potential impact to product quality. As Specialist QA within the Environmental Control Team (ECP), you will serve as the site’s primary contact and liaison to the Amgen Contamination Control network and will represent the site before regulatory agencies on related matters.Specific responsibilities include but are not limited to: Ownership and leadership for the sustainability of the AML Environmental Monitoring program for classified areas and critical utility systems.Deliver expert quality and technical support for the resolution of complex contamination control investigations.Review environmental monitoring data and trend reports, including expert interpretation of raw data from primary sources.Apply the EM subject matter expertise during troubleshooting events and present EM program performance during audits and inspections.Advise on the acceptability of gowning outfits and consumable manufacturing materials, including requirements for implementation within site GMP operational areas.Contribute to the specification and design of garments used in aseptic and cleanroom environments.Drive the design and implementation of procedural controls and sampling strategies to monitor the performance of critical classified manufacturing processing areas.Develop justifications and scientific rationales for the selection of sampling locations within production and engineering systems intended for contamination control.Execute risk assessments to support the sustainability of the site Environmental Monitoring programs.Ensure site alignment with Amgen Contamination Control network multisite procedures, standard practices, and applicable regulations to maintain compliance.Apply statistical tools and methodologies to environmental control trending and monitoring analysis.Develop protocols to mitigate quality and operational contamination events across AML, including cleaning and sanitation procedures, disinfectant implementation and qualification, and microbiological sampling techniques for contamination control prevention.What we expect of you   We are all different! Yet, we all use our unique contributions to serve patients. The Specialist QA professional we seek is a Quality-driven professional with these qualifications.   Basic Qualifications:   Doctorate degree  OR Master’s degree and 2 years of Quality Assurance GMP regulated industry experience OR Bachelor’s degree and 4 years of Quality Assurance GMP regulated industry experience  OR Associate’s degree and 8 years of Quality Assurance GMP regulated industry experience  OR  High school diploma / GED and 10 years of Quality Assurance GMP regulated industry experience  Preferred Qualifications: Educational background in Microbiology, Industrial Microbiology, and/or Life Sciences.Experience working in GMP-regulated manufacturing environments with a strong quality mindset in the production of sterile biological products.Experience in drug product and parenteral manufacturing operations.Experience conducting trending, monitoring, and oversight of cleaned, controlled, and classified environments for sterile and non-sterile manufacturing areas.Proficient in establishing environmental control procedures and assessing gowning systems for personnel working within controlled environments.Experitse in troubleshooting contamination events, determining action plans, and proposing compliant solutions to address complex contamination control problems.Proficient in developing expert protocols to mitigate quality and operational contamination events.Strong experience conducting scientific data gathering, analysis, interpretation, and reporting of expert technical documents to diagnose the state of microbiological control of facilities and critical utilities, including water for injection.Experience with aseptic process validation and/or airflow visualization is a plus.Effective English written and verbal communication skills, with strong project management, presentation, information systems, and interpersonal skills to support performance within complex matrix organizations.What you can expect of usAs we work to develop treatmen