Scientific Data Reviewer
Desired skills: Chemistry, Biology, Scientific Review
Do you pride yourself on your detail orientation skill, ensuring FDA scientific data is correct and enjoy focusing on precision? This could be a great career opportunity!
The Scientific Data Reviewer is responsible for ensuring the scientific integrity, accuracy, and completeness of data for submission to the FDA, in accordance with applicable regulations and BASi procedures. This will involve reviewing studies submitted by laboratory staff in order to provide BASi clients with quality data in a timely manner.
How you can contribute:
- Review of data for the pharmaceutical industry in support of FDA submissions.
- To apply problem-solving techniques and scientific thought processes to review data.
- To review instrument parameters and system suitability requirements per internal protocols.
- Use a variety of software packages to approve raw data.
- Ensure that appropriate federal regulations, study plans, and local SOPs governing studies were applied correctly.
- Verification of scientific calculations for accuracy.
- Ensure that appropriate documentation accompanies all data such that study can be reconstructed.
Education and Experience:
- B.S. in a scientific discipline (chemistry preferred) or
- At least 2 years of direct work experience in a scientific environment (GMP setting preferred).
- Equivalent combination of related education and required work experience will be considered
Skills and Ability:
- HPLC knowledge.
- LC/MS MS experience preferred.
- Familiar with Microsoft Office Excel and capable of learning new software packages.
- Excellent organizational skills and attention to detail.
- Excellent oral and written communication skills.
- Ability to use a personal computer to write reports and verify calculations.
- Ability to comprehend and apply applicable FDA drug regulations.
- Ability to adhere to all safety regulations and procedures.
- Ability to interact with scientific staff at all levels.
EOE
To apply to this position, please use the link below:
Keywords: chemistry, biology, FDA, quality, science, pharmaceutical, contract research organization