Quality Specialist-Analytics

4 months ago


San Diego, United States BioPhase Solutions Full time
Job DescriptionJob DescriptionGENERAL POSITION SUMMARY: Utilizes data analytics skills and tools to analyze vertex data systems and procedures. The individual will support developing and delivering integrated, cross-modality, and cross-GxP metrics and analysis that support quality governance, operational QA management oversight, and other Quality related functions.
Key responsibilities include:
  1. Support the active management of metrics program and Quality data analytics activities.
  2. Support Data acquisition from all applicable systems and create visualizations for Quality leadership team meetings
  3. Create ad-hoc data models, reports and analysis as needed to support business requirements.
  4. Identifying, analyzing, and interpreting trends or patterns in complex data sets
  5. Automate the visualizations as required to improve efficiency
Key Technical Knowledge, Skills and Competencies:
  1. Demonstrated ability to turn data into information that helps drive decisions.
  2. Strong data visualization skills and experience with relevant tools including MS office suite
  3. Strong oral, written and presentation skills with ability to explain complex concepts clearly to a variety of audiences
  4. Understanding of industry requirements/expectations of a Quality Management System
  5. Current knowledge of industry trends and best practices- for progressive quality management in a regulated environment
  6. Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions
PREFERRED EDUCATION AND EXPERIENCE:
  1. M.S. (or equivalent degree) in a quantitative field such as Data Analytics, Econometrics, Economics, Data Science and 2+years of relevant work experience, or B.S. (or equivalent degree) and 4+ years of relevant work experience, or relevant comparable background
  2. Exceptional experience with Power BI and/or other visualization applications
  3. Demonstrable experience in the pharmaceutical, biotechnology or device industry solving business and/or compliance challenges through the application of analytic approaches strongly preferred.
  4. Experience with Veeva QMS/Trackwise system is preferred




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