Process Development Associate I (Data Auditor)

Tampa, FL 33612

Posted: 05/09/2019 Employment Type: Contract Industry: Clinical & Scientific Job Number: 15656
Process Development Associate I (Data Auditor)
Tampa, FL


The Process Development Associate I will provide analytical support to development and research projects, including but not limited to: assess data integrity and accuracy through data audits, data surveys, and final data audit reports.
Specific  Responsibilities
  • Provide support related to data and records management
  • Receive data audit request from research teams and confirm study file location of all data files to be audited
  • Ensure that documentation is appropriately reported and documented
  • Consult with Process Development Scientists to confirm data audit plan
  • Perform data audits and record findings for each step
  • Prepare data audit reports with data audit proof of each step
  • Follow up with corrective action implementation and effectiveness
  • Include corrected data file proof in data audit reports
  • Provide Process Development team and research owner with final data audit reports
  • Send corrected and finalized data files to Document Control to lock data
  • Ensure that the team members are trained and up to date on new processes and analytical methods
Education and Qualifications
  • Bachelor’ s degree (B.S./B.A.) or equivalent, preferably in a life science or STEM related discipline
  • Prefer some biotechnology/life science industry experience (1 to 3 years)
  • Proficiency in Microsoft Office Suite and spreadsheet programs required
  • Proficiency in Graph Pad and FACS DIVA software is desirable
  • Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements and effectively communicate (written and oral) findings
  • Strong interpersonal, written, and oral communication skills are required
  • Must be organized, be able to multi task, and be a team player
Physical Requirements
  •   Lift up to 15 lbs
  • Sit for extended period of time in front of computer (2-4 hour)

Jesse Ashworth

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