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Quality Analyst I

Austin, TX 12345

Posted: 09/19/2022 Employment Type: Contract Job Number: 503834 Country: United States Is job remote?: No

Job Description

  • 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.
  • 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.


Skills:    
  • 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.
  • Requires a minimum of 1 year of practical experience working as a quality assurance professional in a cGMP regulated environment.
  • Able to communicate complex information and ideas so others will understand.
  • 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. 

 

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.

 

Education:    
Bachelor degree required. Science, mathematics, or quality related field preferred.
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