Quality Analyst

Location: 

TX-Austin, US

Contract Type:  Regular Full-Time
Area:  Nursing/Healthcare
Req Id:  428829

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Quality Analyst I
               
    Leveling Chart: Individual Contributor Job Category: Quality    
    FLSA Exemption: Non-Exempt Effective or Revision Date: February 24, 2019    
    Approved By: Chad Westhoven Date: February 24, 2019    
    Supervisor Signature:   Date:      
    Employee Signature:   Date:      
               
  Summary:  
  Under direct supervision, support the quality system by collecting, analyzing, and disseminating performance data used for quality control monitoring, root cause analysis, laboratory performance assessments, and continuous improvement activities.  
     
               
  Primary responsibilities for role:          
  ● Collect quality related performance data from production and laboratory support activities.  
  ● Perform standard data reduction techniques to assess data, and provide weekly and monthly reports to laboratory management.  
  ● Assist laboratory management in gathering, compiling, and analyzing data for investigations, studies, or other special projects.  
  ● Write simple error investigation reports, including determining remedial actions, analyzing and determining error risk and impact, analyzing and determining root cause, and proposing corrective and preventative actions.  
  ● Work on problems of moderate scope where analysis and situations of data requires a review of a variety of factors.  
  ● Conduct investigation meetings of applicable laboratory staff members to apply quality analytical tools to determine root cause of laboratory errors and proposed corrective and preventative actions.  
  ● Communicate performance data with laboratory internal and external customers.   
  ● Assist in internal and external audits.  
  ● Accurately complete detailed documentation as required by established procedures and good documentation practices regulations.  
  ● Effectively communicate with personnel from various departments building productive internal/external working relationships, and escalate issues and identified quality related performance data trends to Quality Management.  
     
               
  This job description is intended to present the general content and requirements for the performance of this job.  The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.  Managers and supervisors may assign other duties as needed.



 

 

   
Specific Leveling Quality Analyst I
   
Job Code QL5401
Additional Responsibilities N/A
Knowledge, Skills, and Abilities A intermediate level of understanding of Microsoft Excel required, including writing basic formulae to extract, reduce, analyze, format, and graph large groups of data. Light statistical analysis background necessary such as population distribution, regression analysis, confidence intervals, linearity, outlier detection, and quality control charting.  Knowledge of Microsoft PowerPoint also required. Knowledge of CAPA system and root cause investigation tools preferred.
Education Bachelor degree required. Science, mathematics, or quality related field preferred.
Experience Typically requires a minimum of 1 year of practical experience working as a quality assurance professional in a cGMP regulated environment.
Equivalency Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. 
Example:  If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience. 
Occupational Demands Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.   Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues. 
Link to complete OD Form:  

Location: NORTH AMERICA : USA : TX-Austin:USAUS - Austin Lab, TX 

 

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