QA Specialist II/III - (Gaithersburg, MD) - Gaithersburg, MD | Biospace
Get Our FREE Industry eNewsletter

QA Specialist II/III - (Gaithersburg, MD)

MedImmune, LLC

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

Job Description

                                       Location:Gaithersburg, Maryland, United States
Job reference: R-002613

Posted date: Jan. 05, 2017



   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 II/III in Gaithersburg, MD, 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  

   This role works in a team to carry out quality control evaluations for specified products and systems within MedImmune/AstraZeneca, either supporting multiple quality control funtions or offering technical expertise in a norrower area. Helps support internal customers dealing with quality issues  and unexpected information.  

   Typical Accountabilities  

  •      Support the validation state of Internal Systems (PMD, RAR, LRA, LIMS)    
  •      Oversee and implement documentation concerning the validation of External Systems (IRT) across the GMP and GCP arenas    
  •      QC review data entered into, existent in, or autonomously generated by Internal and External Systems during system life    
  •      Represent Quality in collaboration activities concerning Internal and External Systems    
  •      Support Packaging and Labeling and Lot Disposition Quality Groups in performance of standard IMP packaging operations    
  •      Carries out technical evaluations of specialized systems or processes in a team of quality professionals    
  •      Gathers and analyses quality related data to ensure a high standard of quality is maintained and identify potential areas of concern    
  •      Provides a basic level of technical support for more straightforward quality related problems    
  •      Helps implement improvements in quality related business process    
  •      Adheres to defined processes and quality management systems    


   Essential Requirements  


  •      Bachelor’s degree required.    
  •      Some understanding of principles, applications and management of Safety, Health and Environment and Good Manufacturing Practice    
  •      Some experience in Operations and/or Research and Development    

   Years of Experience  

  •      3-4 years of related job experience.  Industry experience required.    

   Desirable Requirements  

  •      Professional certification(s) desired.    
  •      Experience with Trackwise and/or non-conformance investigation experience a plus.    

   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.