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Quality Data Review Scientist 

EOE StatementWe are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.
Full-Time/Part-Time Full-Time  

The Chemistry Data Reviewer will be responsible for reviewing and approving technical documents such as method validation/verification protocols and reports, release and stability testing data sheets and laboratory notebooks. This position will perform audit process for all documents under review to support ongoing development; raw material release, product release and stability studies.

Duties /Responsibilities

  • Reviews and approves test data for all analytical instrumentation such as but not limited to FTIR,HPLC,GC,AA and UV/VIS
  • Reviews laboratory investigations such as but not limited to unusual results, out-of-trend and out-of-specification results.
  • Reviews all laboratory documents to support ongoing development activities; raw material release, finished product release and stability studies
  • Reviews documents that support incoming raw material and component release.
  • Applies principles outlined in CFR, ICH, and FDA guidelines
  • Assist with FDA inspections as necessary and/or required
  • Follows requirements of batch records, SOPs, test methods, validation protocols, validation reports, calibration, and change control records to administer quality and compliance into processes
  • Performs other duties as assigned

Direction Received: Light direction that requires only general instruction to begin assigned duties and work is reviewed after completion

Analytical Requirements: Assignments frequently involve decisions based on a wide knowledge of many factors where application of advanced or technical concepts are pedominantly required

Decisions and Judgment: Recommendations based on the development of facts concerning conformity with a known standard or set policy and procedures

Initiative: Procedures are established, but conditions change; initiative must be exercised to overcome minor obstacles

Location Lenexa, KS  

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