Pharmaceutical Chemist III
3 days ago
We are seeking a highly skilled Pharmaceutical Chemist III to join our team at Jobot. As a key member of our Quality Control laboratory, you will be responsible for performing complex analytical testing and troubleshooting on various pharmaceutical products.
Key Responsibilities- Perform analysis in the functional areas of analytical testing using modern analytical equipment such as HPLC, FTIR, UV, GC, ICP, and Wet Chemistry.
- Provide analytical testing in support of production, analyzes Raw Material, In-Process, Finished product, Stability samples, and investigation samples.
- Thoroughly understand and comply with FDA cGMPs, cGLPs, USP, ICH, SOPs, Test Methods, and other recognized standards.
- Support and lead in Analytical and Chemical test method development and test method validations as necessary.
- Write SOPs, test methods, study protocols, reports, and reviews.
- Train lab analysts on analytical test method procedures and usage of equipment and documentation.
- Communicate lab test data, data review, and reporting of OOS/QR/OOT test results to the lab manager.
- Provide ideas/feedback for areas where efficiency can be implemented in the lab through the 5S process improvement program.
- Support all general safety and pharmaceutical compliance requirements.
- Coordinate with calibration services in the upkeep of lab instrumentation.
- Initiate and complete analytical test methods associated with raw materials, finished products, and lab instrumentation.
- Mentor other chemists in the QC laboratory.
- Lead laboratory investigation efforts and draft final reports for review by management.
- Assist with annual management review metrics for QC laboratory functions.
- BS in Chemistry/Biochemistry.
- Minimum 5-8 years in FDA-regulated environment working in QC laboratory.
- Foundation in analytical technique, with hands-on sample preparation and operation of analytical equipment and software required.
- Strong HPLC experience required with troubleshooting skills.
- Experience with GC, FTIR, UV Spec, ICP, and other analytical instrumentation.
- Experience with wet chemistry.
- Experience with data analysis (MS Excel) and proficiency with MS Word required.
- Experience with raw material, stability, in-process, and finished product testing.
- Demonstrate good laboratory practices.
- Participate in research and development projects.
- Strong verbal and written communication skills.
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