Open Rank Quality Assurance Specialist (Entry - Senior)

Job Summary

This position involves the reviewing of data related to patient diagnostic testing under CAP and CLIA regulations, as well as work under the FDA GxPs as involved in new drug development, working largely independently with personal accountability and responsibilities. The individual will need to exercise discretion and analytical skills to investigate and disentangle complicated data processes. This Senior Information Science Professional will utilize applied or computational mathematical analyses for a wide array of different applications with a particular focus on the validation and assurance of quality data. The position will be part of a team doing esoteric and niche testing in complement and autoimmunity. As a member of the Exsera BioLabs Quality Assurance group the candidate will need to be detail-oriented and have a strong interest in advancing human health. After training is complete, a hybrid on campus and work from home schedule may be optimal.

Key Responsibilities

• Work independently but in coordination with the current Quality Assurance team.
• Be part of ensuring quality patient care through work to ensure the accuracy and completeness of clinical trials pharmacodynamic data.
• Assist with data review for a clinical trial.
• Conduct full reviews of data and reports for adherence to the laboratory SOPs and the study protocol.
• Perform accuracy reviews for tabulation of data prior to release to client.
• Assist QA Team in phase inspections and facility inspections.
• Participate in hosting client audits and inspections and participate in visit and inspections.
• Aid in the updating and preparation of laboratory standard operating procedures and controlled documents.
• Participate in CAPA investigations and improvement activities.
• Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration (FDA).
• Independently master study materials, including but not limited to protocols and all other essential study documents for assigned studies.
• Independently perform study quality assurance related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies.
• Assist Senior Quality Assurance staff on multiple trials/studies.