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Analytical Data Reviewer / Technical Writer
Boulder, CO 80301 US
2023-05-17
2023-07-08
Job Number: AM49239758
Pay Rate: $30-36 / hour
Job Description
Hybrid Analytical Data Reviewer needed ASAP!
Role:
Reviewing GMP and GDP scientific testing data from the laboratory to ensure that throughout the pharmaceutical production the processes documentation verifies results, accuracy 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
