Research Associate I
2 weeks ago
- Perform testing and data recording of API samples, Development Product samples, Validation samples, Stability samples, Bulk hold samples, RLD samples, PDR samples, and other necessary samples according to the approved Method of analysis or current Pharmacopoeia.
- Operate various instruments like HPLC, GC, Balance, Auto titrator, Karl Fisher Titrator, pH meter, and other necessary equipment as per approved standard operating procedures.
- Calibrate Instruments (Daily/as per schedule) like HPLC, GC, Balance, Auto titrator, Karl Fisher Titrator, pH meter, and other necessary equipment as per approved standard operating procedures.
- Make entries in the respective logbook when starting analysis and at the completion of 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.
- Follow good Laboratory Practices in the Department.
- Follow the instruction and procedure as mentioned in the approved protocol.
- Keep track of routine requirements, inform, and ensure timely procurements of the same to the respective person or Department.
- Report and investigate any failure/abnormal observation/deviation/non-Compliance to the sub-department manager and seeking for the solutions.
- Communicate project-related issues to the sub-department manager and follow the action plans.
- Check the trend of results before reporting the results.
- Keep the status of daily work and report to the sub-department manager on a daily basis.
- Prepare Standard Operating Procedures (SOPs) and standard formats for Documentation.
- Verify the instruments after maintenance of the Instruments.
- Check preventive maintenance, Breakdown Maintenance, and perform risk assessment. Report preventive maintenance and Breakdown Maintenance to the sub-department manager.
- Represent subject matter expertise in the areas of analysis internally and externally as needed.
- Making analytical problem-solving efforts to meet urgent business needs.
- Focus on innovation, process improvement, and/or operational excellence.
- Execute and manage projects/programs utilize 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.
Baxter is deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics, and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful, and inspire each other. This is where you can do your best work.
We are committed to saving and sustaining lives.
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