Description:
Our Pharmaceutical client is looking for a QC Scientist 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
Rockville MD: QC Scientist- Method Validation (232214)
#LI-JM2
