QA Specialist III - Boulder, CO | Biospace
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QA Specialist III

MedImmune, LLC

Boulder, CO
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

                                       Location:Boulder, United States
Job reference: R-001678
Posted date: Nov. 30, 2016


   If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.  

   MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.  As a QA Specialist III in Boulder, CO, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.  

   We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.  

   MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.  

   Main Duties and Responsibilities  

   When the shift operations begin, you will work 4th shift; Saturday to Monday, 0700 to 1930.    


   As QA Specialist III, you will be utilizing quality assurance systems in compliance with current good manufacturing practice regulations and corporate policies and procedures. You will support the evaluation and disposition of labeling, raw materials, intermediates and finished products through timely compliance evaluation of batch records, laboratory results, and other cGMP documents. You will Support the identification of root causes, recommends and implements corrective actions to prevent recurrence. As well as perform trend analysis to monitor process and facility performance and employs metrics to track the performance of operations and quality systems. You will be Supporting audits of manufacturing, analytical testing, contractor/supplier or labeling areas to ensure compliance with SOP and regulatory requirements per the requirements of the self-inspection program. Your duties will also include, providing leadership and guidance to peers in the QA department and functional areas. You may assist in the training activities of other QA personnel. As well as assist with coordination of the self-inspection program and conducts audits as required and assist with the coordination of the inspection readiness program and with any site audits. You will manage workflows to assure a timely supply of product. Finally, you will be administering the change control and Deviation and corrective action systems for assigned products and quality systems.   




   Essential Requirements  

  •      Seven to ten years of experience in biopharmaceutical/pharmaceutical industry including previous quality assurance experience.    
  •      Ability to work 4th shift; Saturday to Monday, 0700 to 1930.    

   Desirable Requirements  

  •      Bachelor's degree in engineering, chemistry, biology or related science field. May substitute additional four years of experience for degree.    
  •      Excellent writing, verbal and listening skills.    
  •      Presentations/reports to senior management and high-level industry audiences.    
  •      Effectively drives solutions and improvements for highly complex, critical cross-functional and corporate projects.    

   Next Steps – Apply today!  

   To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.  



   AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.