Data Specialist / Report Writer

Bioanalytical Data Specialist/Report Writer

 Responsibilities

?  Assisting the laboratory with the compilation of study data for archiving.

?  Issuance of final GLP reports for both method validations and study samples results.

?  QC review of all laboratory documentation including GLP documentation.

?  Generation and transmission of data reports to clients.

?  Writing, editing and distribution of sample analysis final reports.

?  Utilization of the Watson? DMLIMS database for generation of data tables and graphics included in the final report.

?  Production of graphics, such as representative chromatograms, from mass spectrometer software for insertion in the final reports.

?  Tracking the progress of final reports from inception to delivery of the report to the client in conjunction with the project manager.

Must have knowledge and Special SkillsGLPScientific report writingWord and Excel expertMin. B.Sc. in chemistry or equivalent

 

Suitable candidates will have 2 years hands-on in the laboratory running LC/MS/MS and/or immunoassays in a regulated environment (GLP/GMP/CLIA). They will have been previously employed in a CRO, clinical laboratory, medical device, or an in vitro diagnostics Company as well as experience in a Quality or Regulatory environment, managing data, writing reports summarizing testing and clinical trial results, and or preparing documents for regulatory submissions.

 Environment

 

Member of a project team which includes scientific staff and a Project Manager.  The position includes close interaction with fellow Data Specialists, especially during training.  The position will also include interaction with the Quality Control department, Quality Assurance department and Sample Management. This is a fast pace environment.