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Analytical Research Scientist
2 months ago
- Support validation activities of analytical methods and method transfer from R&D to QC laboratories as per the current SOPs, ICH, and FDA guidelines.
- Conduct routine and non-routine laboratory analyses such as finished product testing, stability testing, and manufacturing in-process testing of R&D/engineering batches which requires critical levels of accuracy.
- Use analytical techniques like HPLC/UPLC, GC using empower software, Karl Fisher, UV spectrophotometer, etc. that is used in analytical development activities.
- Author standard methods of analysis. Author and review analytical test methods, reports, and protocols.
- Operate all laboratory analytical instrumentation and perform troubleshooting and calibrations of laboratory equipment as needed. Perform assigned various tasks which are needed to maintain the laboratory.
- Manage time effectively to complete assignments in an expected timeframe.
- Document all experimental work neatly and correctly in a lab notebook in accordance with SOPs. Review lab testing results and notebooks to ensure accurate documentation.
- Ensure proper training before performing any tests and maintain an up-to-date training record related to all job functions and GXP requirements.
- Maintain quality checks on safety of the lab, including biohazards and ensure maintenance of the facilities according to GLP.
- Comply data and interpret any out of trend/specification against predetermined validation criteria and update R&D Management accordingly.
- Effectively interact with other scientist, project managers, and colleagues from numerous functions.
- Understand and comply with all Renaissance safety, environmental, and quality practices and procedures as outline in SOPs and federal, state, and local regulations.
- Bachelor's of Science Degree in Biochemistry or Chemistry
- 1-5 years of analytical laboratory experience in Pharmaceutical industry
- Experience with method validation is required and method development is preferred.
0 Yearly Salary
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