Job: Data Reviewer, Tergus Pharma, Durham, NC
The Data Reviewer reviews data generated by In-Vitro Release Testing and In-Vitro Penetration Testing Laboratories. Included in this review are physical testing results, HPLC-MS, HPLC, GC, solution preparation IVRT analysis, IVPT analysis among other analyses. In addition to data review, this individual could be responsible for preparing and/or reviewing documents, composing SOP’s, Methods, Work instructions, and Reports, Data Reviewer is responsible for reviewing with knowledge of DEA, FDA, and ICH guidelines, as GDP, GLP and other regulatory guidelines as needed.
Summary of Key Responsibilities:
• Ensure the integrity of the data generated in the IVRT and IVPT Laboratories, related to testing
• Review of all the testing performed by the analysts and associated documentation for accuracy and cGMP compliance as well as GLP compliance; Includes responsibility for review of laboratory instrument calibration status, logbook entries, calculation verifications, IQ/OQ/PQ etc. on routine basis.
• Audits system audit trails in the Empower software, UV software and GC software
• Assist in review of Laboratory investigations, deviation reports and reports to assure complete complaint data using a solid foundational knowledge of GMP’s.
• Review multiple projects in a concurrent manner of a routine basis.
• Interact with Quality assurance on routine basis on the data submitted and correction if any.
• Discuss the questions or potential discrepancies in laboratory documentation and audit trails with the supervisors and analysts; work toward resolution prior to escalation, where possible.
• Review of method validations/verifications/Method transfers protocols, data and reports.
• Participate in review of Lab deviations, investigation and Audits if necessary.
• Review of test methods, specifications, protocols and reports.
• Knowledge and understanding of cGMP’s, Good Laboratory Practices and Good Documentation Practices.
• Demonstrate professionalism to coworkers, customers and an understanding of quality in a regulatory industry.
• Other duties as assigned
Required Qualifications and Skills
• Minimum B.A. or B.S. required.
• Minimum 3 years in an official review role of GMP/GLP data preferred
• Knowledge of cGMP’s
• Good communication, organization and computer skills are required.
• Knowledge of Empower required; Microsoft Office programs knowledge is desired
• Ability and willingness to work additional hours only as required by business need
• Excellent interpersonal skills and ability to establish and maintain effective working relationships
• Ability to work with minimal supervision
• Experience establishing and maintaining relationships with key decision makers
• Strong analytical skills and ability to understand business and financial implications of contracts.