Process Development Associate I (Data Auditor)

Process Development Associate I (Data Auditor)

Process Development – Tampa, Florida

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)