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Research Scientist I
4 weeks ago
We are seeking a highly skilled Research Scientist I to join our team at Baxter. As a key member of our R&D department, you will play a critical role in developing and validating analytical methods for our products.
Key Responsibilities- Perform testing and data recording of API samples, development product samples, validation samples, stability samples, and bulk hold samples according to approved methods of analysis or current pharmacopoeia.
- Operate various instruments such as HPLC, GC, balance, auto titrator, Karl Fisher titrator, and pH meter as per approved standard operating procedures.
- Calibrate instruments daily or as per schedule as per approved standard operating procedures.
- Make entries in respective logbooks when starting and completing analysis.
- Use live reference standards, working standards, and impurity standards for analysis and maintain their records.
- Verify the shelf life of chemicals and reagents before performing analysis of material or product.
- Follow good documentation practices and good laboratory practices in the department.
- Follow instructions and procedures as mentioned in approved protocols.
- Keep track of routine requirements and inform and ensure timely procurements of the same to respective persons or departments.
- Report and investigate any failure, abnormal observation, deviation, or non-compliance to sub-department manager and seek solutions.
- Communicate project-related issues to sub-department manager and follow action plans.
- Check the trend of results before reporting results.
- Keep the status of daily work and report to sub-department manager on a daily basis.
- Prepare standard operating procedures (SOPs) and standard formats for documentation.
- Verify instruments after maintenance of instruments.
- Check preventive maintenance, breakdown maintenance, and perform risk assessment. Report preventive maintenance and breakdown maintenance to sub-department manager.
- Represent subject matter expertise in areas of analysis internally and externally as needed.
- Make analytical problem-solving efforts to meet urgent business needs.
- Focus on innovation, process improvement, and/or operational excellence.
- Execute and manage projects/programs utilizing established methods, techniques, or approaches.
- Implement new or improved techniques and procedures around specific tasks; write and implement SOPs.
- Maintain knowledge of relevant regulatory requirements related to R&D to ensure compliance in all research, data collection, and reporting activities.
In addition to having an in-depth knowledge and understanding of cGxP and related regulations and guidance, you will be required to have excellent analytical and problem-solving skills, as well as the ability to work independently and as part of a team.
