Sr. Quality Assurance Specialist Altimmune, Inc.
THIS JOB HAS EXPIRED JOB DUTIES:
This position within the Quality Assurance program provides day-to-day management of functions to support product development, manufacture, testing, and release of clinical trial and nonclinical materials in accordance with regulatory requirements and quality standards. This position is required to work with both internal and external parties to provide direction on compliant operational practices. This position will provide review of production and testing raw data / reports, work with various groups / vendors to oversee investigations, design / utilize quality systems, and compile / present quality metrics. Assist in preparing PowerPoint presentations on progress in company Quality Systems and Quality and Regulatory strategies. Participate in compiling and reviewing regulatory submissions. May occasionally travel nationally/internationally and represent the company during audits.
- Bachelors degree in science, pharmacy or engineering required, Masters degree preferred
- Five to ten years of compliance-related experience with regulated activities
- Compliance experience at a biotechnology/pharmaceutical organization
- Working knowledge of US and European GLP, GMP, and GCP regulations preferred
- Experience with vendor auditing / management and investigations preferred
- Skills in regulatory inspection / management and project management
- Ability to work in a collaborative environment
- Proficiency in Microsoft Office Suite
||Gaithersburg, MD |
THIS JOB HAS EXPIRED
Altimmune (formerly known as Vaxin) is focused on products that engage the immune system to prevent and treat disease. We strategically employ our two distinct and complementary immune platform technologies to create innovative products for important diseases.
Beta Test / Clinical Trials Investors: Redmont Venture Partners All Jobs: at Altimmune, Inc.
|Headquarters:||19 Firstfield Road|
Gaithersburg, MD 20878
|Company Profile:||Altimmune is a clinical stage immunotherapeutic biotechnology company located in Montgomery County, MD with additional operating sites in London, UK and Strasbourg, France. By leveraging the complementary attributes of its two innovative vaccine delivery platforms, RespirVec- and Densigen-, Altimmune is able to rationally design and rapidly develop immunotherapeutic products tailored to address the a wide range of disease indications including acute respiratory infections, chronic viral infections and cancer with fundamental advantages over competing products.|
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