Technical Report Writer/Data Specialist - Full-time / Part-time

Scope of Responsibilities: The major duties and responsibilities of the Data Specialist II include the following: 1. Proficient in all the job responsibilities of a Data Specialist I. 2. Data: Generating and sending validation tables to clients. 3. Reports: Report should accurately reflect the raw data. Writing, editing, distribution and finalization of method validation, addendum, and stock stability shell reports. 4. QAIR: Respond to more complex QA inspection report findings. 5. Watson: More advanced navigation including updating assays and creating studies. 6. Coordination: Ability to independently ascertain project status and communicate with appropriate people as issues arise. Able to handle multiple client projects at once. Work independently on special projects (such as guidelines and client profiles) as needed. 7. Peer Review: Peer review validation, addendum and shell study reports, and validation data tables written/generated by other data specialists, including verification of the accuracy and completeness of the associated raw data package. 8. Process Improvement: Actively involved in improving processes, including participating on Quality Improvement Teams as needed. 9. Other duties as assigned. Working Structure: Business Environment Exposure Potential: Not exposed to chemicals or biohazards during the performance of routine or non-routine job responsibilities. Scope of Authority and Decision Making: The Data Specialist II works with the DS Lead on the day to day priorities of the department and consults with Lead and/or Manager and/or PM on ambiguous or unusual situations. Organizational Framework: Reports to DS Manager (SL). Receives daily instruction from the DS Lead who reports to the DS Manager. Internal and External Relationships: Internal: Works closely with other data specialist team members and Project Managers. Also interacts with QA auditors, QC personnel, and Laboratory Directors for data and/or report reviews. External: Some client interaction via e-mail, but generally only to send them data and reports. Occasional conference calls may be required for some projects.