QA Specialist III - (Frederick, MD) - Frederick, MD | Biospace
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QA Specialist III - (Frederick, MD)

MedImmune, LLC

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Location:
Frederick, MD
Posted Date:
3/26/2017
Position Type:
Full time
Job Code:
R-004647
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

                             
                                       Location:Frederick, Maryland, United States
Job reference: R-004647

Posted date: Mar. 21, 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 III in Frederick, 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  

   Scope  

 
       
  •      Responsible for assuring the quality of commercial and clinical products manufactured at the facility.    
  •    
  •      Supports functional areas including manufacturing, facilities and other Quality departments.    
  •    
  •      Implements quality policies for process improvements.    
  •    
  •      Utilizes quality assurance system in compliance with current good manufacturing practices.    
  •    
  •      Maintains database, generates routine reports.    
  •    
  •      Change management utilizing a risk based approach.    
  •    
  •      Electronic system usage with tools such as Trackwise and SAP.      
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  •      Ability to learn the use of Operational Excellence tools such as DMAIC and root cause analysis.    
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  •      Ability to communicate and work effectively with internal customers.      
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  •      Demonstrated technical ability and skills in assigned work area to include product, process and/or testing knowledge.      
  •    
  •      Ability to review and understand analytical data.   Ability to understand and implement priorities and work load and to establish strong collaborative relationships with peers.    
  •    
  •      Author documents, and participate in change review of SOPs.    
  •    
  •      Support collection of metrics to track performance.    
  •    
  •      Support departmental projects.    
  •  

   In addition to the above, a Quality Specialist III working within Quality-ATS would also perform:  

 
       
  •      Supports the evaluation and lot disposition of intermediates and finished bulk drug substance through timely review of batch records, laboratory results and other GMP documents.    
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  •      Performs on the floor inspections of the production areas to resolve issues early and to ensure compliance with SOP and regulatory requirements.    
  •    
  •      Identifies and assesses the impact of minor and major deviations that may occur during manufacture.    
  •    
  •      Performs preliminary risk assessment of non-conformance events and assigns criticality levels, including as applicable, identification of root causes and establishment of corrective actions.  Approves closed event non-conformances.    
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  •      Reviews, assess and approve change controls and level 1 and 2 non-conformances and corrective actions.    
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  •      Acts as back-up for other Quality Units in off-hours. Re-issues batch record pages; issues logbook pages, SPRs and MPRs.    
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  •      On the floor Batch Production Record and autoclave review.    
  •    
  •      PCS alarm review.    
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  •      Assist in product changeover, zone promotions, placing QA hold tags, logbook extensions.    
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  •      Performs Return to Service of areas and equipment.    
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  •      Routinely provides compliance guidance to Manufacturing team.    
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  •      Review and disposition process intermediates in SAP.    
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  •      Assists in the compilation and publication of quality metrics for Manufacturing and QA activities.  Performs trend analysis to monitor process and facility performance.    
  •    
  •      May serve as a QA-ATS representative for project teams.    
  •  

Requirements

   Essential Requirements  

   Education  

 
       
  •      BS Science (e.g. Biology, Chemistry) or Engineering (e.g. Biochemical, Chemical, Mechanical) Preferred    
  •  

   Experience  

 
       
  •      Bachelor's Degree with minimum 5 years of biotech/pharmaceutical industry experience. Minimum 3 years of Quality Assurance experience.    
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  •      Master’s Degree with minimum 1 year of experience in biotech/pharmaceutical Quality Assurance. Experience working in a highly regulated environment (FDA, EMA).    
  •  

   Knowledge  

 
       
  •      Good understanding of basic scientific principles.    
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  •      Understanding of basic biotech manufacturing processes.    
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  •      Good understanding of cGMPs, regulatory standards and concepts.    
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  •      General knowledge of other related disciplines.    
  •  

   Problem Solving  

 
       
  •      Develops solutions to a wide range of difficult problems.    
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  •      Solutions are imaginative, thorough, practicable, and consistent with organizational objectives.    
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   Interpersonal Communication  

 
       
  •      Frequent inter-organizational and outside customer contacts.    
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  •      Represents the organization in providing solutions to difficult technical issues associated with specific projects.    
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  •      Excellent written and oral communication skills.    
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  •      Excellent collaboration skills, with focus on customer service    
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  •      Experience working effectively with cross-functional teams with representatives from various departments and levels.    
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   Desirable Requirements  

   Impact  

 
       
  •      Ensures compliance to cGMPs and identifies potential compliance risks.    
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  •      Contributes to the completion of specific programs and projects.    
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  •      Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.    
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  •      Ability to release solutions, process intermediates and raw materials for further manufacturing use.    
  •  

   Freedom to Act  

 
       
  •      Works independently under general direction.    
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  •      Independently determines and develops approach to solutions.    
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  •      Work is reviewed upon completion for adequacy in meeting objectives.    
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   Supervisory/Management Skills  

 
       
  •      Assists in oversight of complex projects and programs, interdepartmental and corporate goals.    
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  •      Supports strategy.    
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  •      May assist in the supervision of activities of other QA Specialists.    
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  •      Assists is training of other specialists.    
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   Change Management and Collaboration  

 
       
  •      Supports development and design of change initiatives.    
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  •      Participates in the evaluation of corporate business processes and proposes improvements.    
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  •      Leads strategic planning where impact is interdepartmental.    
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  •      Effectively drives solutions and improvements for complex, critical cross-functional projects.    
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   *This is a night shift position.  Candidates must be open to working a night shift schedule (6pm-6:30am).  

   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.  

   ~BSP  

 

   *LI-MEDI