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Analytical Data Reviewer / Technical Writer

Boulder, CO 80301

Job Number: AM49239758 Pay Rate: $30-36 / hour

Job Description

Hybrid Analytical Data Reviewer needed ASAP! 
Reviewing GMP and GDP scientific testing data from the laboratory to ensure that throughout the pharmaceutical production the processes documentation verifies resultsaccuracy and compliance. APPLY ASAP! 
Schedule: Monday – Friday, 40 hours a week
Position Type: Long term Contract (call to discuss details)
Location: R&D Department in Boulder, CO
Pay: $30- $36 / Hour 
Day to day:
  • Performs full review of analytical testing data used in pharmaceutical productions working with the QC team
  • Verifies calculations, document versions, supporting logbook data, raw data (e.g., chromatography data, integrations, calibrations, and system suitability) and transcription of data into final reports
  • Ensures compliance with GxPs, SOPs, and Client requirements within clinical, registration and validation programs, with clinical phase appropriate (pre-clinical to phase III) review
  • Performs comparison of results to specifications and batch records
  • Participates in reviewing and drafting of various documents including:
    • transfer, verification, and validation protocols and reports
    • Project reports pertaining to analytical method development and qualification
    • Change control documentation in support of analytical activities required for manufacturing process start up
  • Reviewing data and documentation including: 
    • Raw materials, in-process samples, API-release lots, validation/transfer data and stability results from (R&D) or Standards and Stability (S&S) Analytical Chemists
Background Profile:
  • Bachelor’s degree in Chemistry (Or similar) 
  • 2 years+ relevant experience working in pharmaceutical or other regulated science field in a laboratory setting
  • QC developmental chemists encouraged to apply 
  • Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. 
  • Ability to apply statistical concepts such as significant figures and analysis of variance.
  • Attention to detail and accuracy driven 
Apply Online

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