Description:
Our Pharmaceutical client is looking for a QC Scientist for a 3-6+ month assignment to perform analytical development, verification, validation, and routine quality control operations, to evaluate the quality of products through testing and to support Quality Unit activities.
Responsibilities:
- Execute method optimization activities
- Complete method transfer from R&D to QC
- Conduct verification and/or validation of analytical methods
- Independently generate sound analytical data and produce the associated technical reports
- Writing and/or approval of qualification, validation, and stability protocols and/or reports
- Perform QC testing and/or release of cGMP materials as needed
- Review and approve analytical data and results
- Maintain data within company data integrity standards
- Assist with other analytical services as needed
Skills:
- cGMP training including FDA and ICH guideline
- Ability to write/type/review large volumes of information with excellent attention to detail
- Ability to operate, troubleshoot, and maintain analytical instrumentation
- Ability to write instrumental protocols and instructions
- Ability to develop and troubleshoot analytical methods
- Experience in modern analytical techniques including HPLC, GC, Mass Spectrometry etc.
- Demonstrate excellent attention to detail, ability to learn instrumental techniques, and maintain good record keeping
- Ability to work collaboratively with multi-disciplinary cross-functional research teams
Education:
- Minimum of a bachelor’s degree in chemistry, pharmaceutical sciences or related field; or training and equivalent work experience at a level that equates to B.S. degree
- Minimum 3-5 years of experience of analytical testing in a pharmaceutical Quality Control or Analytical Development Laboratory environment
MD: QC Scientist- Method Validation (233277)
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