Senior Associate Investigator - Boulder, CO | Biospace
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Senior Associate Investigator

MedImmune, LLC

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

Job Description

                                       Location:Boulder, Colorado, United States
Job reference: R-007128

Posted date: May. 08, 2017



   At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Senior Associate Investigator in Boulder, CO, you’ll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients’ lives.  

   Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.  



   Main Duties and Responsibilities  

   You will be responsible for the initiation, ownership, management, and documentation of Major and Minor site deviation investigations and minor site safety event investigations.  You will maintain presence on the manufacturing floor to gather data and observe processes.  Objectively leadminor
deviation investigative teams of relevant stakeholders to determine breadth, scope, product impact, and root cause(s) of deviations. Assist lead investigators for major and critical deviations.
 Deliver thorough, well documented investigation reports within required timeframes to meet business and compliance needs.  Recommend and facilitate the implementation of CAPA plans, with actions having “line of sight” to the identified root causes, to prevent recurrence.  Effectively collaborate across functions including Manufacturing, Quality, Manufacturing Sciences and Technology, Engineering, and Supply Chain operations focused on high-quality investigations, meaningful corrective actions, and reduction of deviations.  Manage multiple ongoing investigations concurrently.  Actively utilize and champion the use of lean tools, problem solving tools, and human performance tools in the performance of investigations, the development of corrective actions, and the improvement of site processes and performance.  Author, review, maintain, and approve procedures within GMP systems.  

   Work is performed without appreciable direction and dependent on level, limited supervision and minimal instructions needed on routine work.  Ensure that investigation and projects are completed on schedule following established procedures and schedules.  


   Essential Requirements    
  •      Ten years’ experience with High School Diploma; Seven years’ experience with Associates degree; Five years’ experience in GMP manufacturing and / or technical or quality support of GMP operations with Bachelor’s degree.    
  •      Ability to thoroughly investigate deviations, perform root cause analysis, and propose solutions through verbal and written communication    
  •      Ability to apply principles of logic and scientific thinking to a wide range of practical problems    
  •      Ability to make and act on routine decisions    
  •      Good organizational skills    
  •      Good communication skills, both verbal and written, and effective presentation skills    
  •      Working knowledge in the application of problem-solving and root cause analysis tools.    
  •      Technical writing experience.    
  •      Ability to analyze data and draw conclusions.    
  •      Meeting facilitation, conflict resolution, and negotiation abilities.    
  •      Knowledge of cGMP standards, and the current code of Federal Regulations (CFR).    
   Desirable Requirements    
  •      BS/BA in engineering, biological sciences or life sciences, or equivalent field of study    
  •      Biopharmaceutical manufacturing processes, systems, and equipment or equivalent field    
   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.