Senior Formulation Analytical Scientist
Maintain a working knowledge of cGMP, DEA requirements and FDA guidance documents.
- Accomplish feasibility studies on potential projects in coordination with Business
- Write analytical methods, SOPs, protocols and validation reports for the analysis of tablets,
- Manage all technical aspects of analytical chemistry to support the product development
- Review instrument IQOQPQ protocols and SOPs.
- Transfer, develop, and validate analytical methods and specifications.
- Create and review the specifications of Raw Materials, In Process Products, Finished
- Analyze Raw Materials, In Process Products, Finished Products and Stability Samples and monitor, evaluate and summarize analytical results in support of development projects.
- Supervise/train associate analytical scientists and technicians to ensure their activities
- Supervise/train associate analytical scientists and technicians to troubleshoot and review
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Packaging Analytical Scientist II
- Analytical lead on small sparkling package project
- Subject matter expert on PET authorization tests
- Train and manage technicians on routine analytical testing
- Implementing new database system to increase workload capacity and minimize data errors
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Analytical Scientist, R & D
- Performs analysis of finished products, validation samples, in-process materials and raw materials, according to the effective protocols, Methods and Compendials
- Collaborate developing new analytical methods or modifies current methods, able to participate in method transfers and assist with developing transfer protocols.
- Verifies co-workers calculations in notebooks/logbooks and verifies results in reports and/or appropriate systems to check for accuracy and integrity of data.
- Prepares reagents, standards, medias, etc. needed for analysis. Performs testing in compliance with cGMP and current safety regulations.
- Provide training to new or existing personnel
- Collaborate with the LIMS system as template specialist.
- Support QC and Analytical R&D DEA system.
- Completes any other duties assigned by QC and Analytical R&D management as required. Work on special projects as needed.
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