QA Specialist III/IV - (Gaithersburg, MD) - Gaithersburg, MD | Biospace
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QA Specialist III/IV - (Gaithersburg, MD)

MedImmune, LLC

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Location:
Gaithersburg, MD
Posted Date:
5/23/2017
Position Type:
Full time
Job Code:
R-007114
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

                             
                                       Location:Gaithersburg, Maryland, United States
Job reference: R-007114

Posted date: May. 08, 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/IV 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  

   QA Specialist III  

   Position Summary:  

   Your responsibilities and experience may include the following: Auditing (internal and external - utilizing risk based strategy. Document systems.  Change management utilizing a risk based approach. Operational Excellence utilizing tools such as DMAIC and root cause analysis. Quality at the source utilizing on the floor real time review of batch records. Electronic system utilizing tools such as Trackwise and SAP. Product release utilizing systematic process flows. Review documents such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, technical reports, etc., that are submitted to QA for approval. Interprets and implements quality procedures, manages quality systems and assists in facilitating regulatory compliance inspections.  

   Essential Job Functions:  

 
       
  •      Responsible for auditing internal and external-utilizing a risk based strategy.    
  •    
  •      Change management utilizing a risk based strategy.    
  •    
  •      Utilizes Operational Excellence tools such as FMEA, DMAIC and root cause analysis.      
  •    
  •      Quality at the source utilizing on the floor real time review and investigations.    
  •    
  •      Supports and provides advice to a number of functional areas including manufacturing, facilities, IT and other Quality departments.    
  •    
  •      Interprets and implements quality procedures, manages quality systems and assists in facilitating regulatory compliance inspections.    
  •    
  •      Reviews documents such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, technical reports, etc., that are submitted to QA for approval.    
  •  

   Additional Job Functions:  

 
       
  •      Utilizes quality assurance system in compliance with current good manufacturing practice regulations.    
  •    
  •      Administers the change control and Deviation and corrective action systems for assigned products and quality systems.    
  •    
  •      Maintains database; generates standard and ad hoc reports.    
  •    
  •      Manages workflows to assure timely supply of commercial product.    
  •    
  •      Supports 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.    
  •    
  •      Investigates and assesses the impact of minor and major deviations that may occur during manufacture, testing, or distribution of products or during the administration of quality systems.    
  •    
  •      Identifies root causes, recommends and implements corrective actions to prevent recurrence.    
  •    
  •      Performs trend analysis to monitor process and facility performance.    
  •    
  •      Employs metrics to track the performance of operations and quality systems.    
  •    
  •      Reviews validation protocols and summary reports.    
  •    
  •      Supports other groups on completion of annual review and annual product reports.    
  •    
  •      Performs in-plant inspections of active production areas to resolve problems early and to ensure compliance with SOP and regulatory requirements.    
  •    
  •      Some 2nd shift work required as per departmental need.    
  •  

   QA Specialist IV  

   Position Summary:  

   Your responsibilities and experience may include the following: Auditing (internal and external - utilizing risk based strategy. Document systems.  Change management utilizing a risk based approach. Operational Excellence utilizing tools such as DMAIC and root cause analysis. Quality at the source utilizing on the floor real time review of batch records. Electronic system utilizing tools such as Trackwise and SAP. Product release utilizing systematic process flows. Review documents such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, technical reports, etc., that are submitted to QA for approval. Interprets and implements quality procedures, manages quality systems and assists in facilitating regulatory compliance inspections. Assist QA management to develop the department budget and analyze headcount requirements.  May travel internationally and represent company during audits.  

   Essential Job Functions:  

 
       
  •      Responsible for auditing internal and external-utilizing a risk based strategy.    
  •    
  •      Change management utilizing a risk based strategy.    
  •    
  •      Operational excellence utilizing tools such as FMEA, DMAIC and root cause analysis.      
  •    
  •      Quality at the source utilizing on the floor real time review and investigations.    
  •    
  •      The QA Specialist supports and provides advice to a number of functional areas including manufacturing, facilities, IT and other Quality departments.    
  •    
  •      Interprets and implements quality procedures, manages quality systems and assists in facilitating regulatory compliance inspections.    
  •    
  •      Reviews documents such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, technical reports, etc., that are submitted to QA for approval.    
  •    
  •      Assists the QA Manager to develop the department budget and analyze headcount requirements.    
  •    
  •      May supervise the activities of other QA Specialists.    
  •  

   Additional Job Functions:  

 
       
  •      Utilizes quality assurance system in compliance with current good manufacturing practice regulations.    
  •    
  •      Administers the change control and Deviation and corrective action systems for assigned products and quality systems.    
  •    
  •      Maintains database, generates standard and ad hoc reports.    
  •    
  •      Manages workflow to assure timely supply of commercial product.    
  •    
  •      Supports 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.    
  •    
  •      Investigates and assesses the impact of minor and major deviations that may occur during manufacture, testing or distribution of products or during the administration of quality systems.    
  •    
  •      Identifies root cause, recommends and implements corrective actions to prevent recurrence.    
  •    
  •      Performs trend analysis to monitor process and facility performance.    
  •    
  •      Employs metrics to track the performance of operations and quality systems.    
  •    
  •      Reviews validation protocols and summary reports.    
  •    
  •      Support other groups on completion of annual review and annual product reports.    
  •    
  •      Performs in-plant inspections of active production areas to resolve problems early and to ensure compliance with SOP and regulatory requirements.    
  •    
  •      Some 2nd shift work required as per departmental need.    
  •  

Requirements

   Essential Requirements  

   Typical Education:  

 

   B.S. in Biology, Chemistry, Engineering or related fields preferred.  Specialist position based on education.  

   Typical Experience:  

 

   QA Specialist III - 5+ years experience.  

 

   QA Specialist IV – 7+ years experience.  

   Desirable Requirements  

   QA Specialist III and IV  

   Knowledge  

 

   Complete understanding and wide application of technical principles, theories and concepts in the field.  General knowledge of other related disciplines.  

   Problem Solving  

 

   Provides technical solutions to a wide range of difficult problems.  Solutions are imaginative, thorough, practicable and consistent with organizational objectives.  

   Discretion / Latitude  

 

   Works under only general direction.  Independently determines and develops approach to solutions.  Work is reviewed upon completion for adequacy, in meeting objectives.  

   Impact  

 

   Contributes to the completion of specific programs and projects.  Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.  

   Liaison  

 

   Inter-organizational and outside customer contact  

   Language Skills  

 

   Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations.  Ability to write reports, business correspondence and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.  

   Mathematical Skills  

 

   Ability to work with mathematical concepts such as probability and statistical inference and fundamentals of plane and solid geometry and trigonometry.  Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.  

   Reasoning Ability  

 

   Ability to define problems, collect data, establish facts and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.  

   For QA Specialist IV - Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.  

   Computer Skills  

   QA Specialist III - Outlook, Access, TrackWise, LMS, EDMS, Visio, SAP, Microsoft Project, Excel, Word  

   QA Specialist IV - Outlook, Deviation, CR Tracking Software, EDMS, Explorer, Excel, Word, MS Office  

   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.  

   ~BSP  

 

   *LI-MEDI