About Us - Human Resources - Quality Control Chemist
Quality Control Chemist
 
  • BS in Chemistry, Biochemistry or related degree concentration
  • Minimum 4-5 years of experience in QC laboratory under cGMP environment, experience with chromatographic data acquisition software (e.g. Waters Empower) is a must
  • Strong understanding of cGMPs
  • HPLC experience – minimum 1 year experience
  • Empower 2 or 3 experience
  • USP dissolution testing experience
  • Excellent oral and written communication skills are essential and well acquainted with current analytical techniques (e.g, separation technology, spectroscopy, etc.), wet chemistry and dissolution testing
  • Professional work ethics

    Responsibilities For:

  • 1. Testing and release of finished products, stability samples, raw materials, registration, clinical and marketed products batches under cGMP/GLP environment as per company's standard operating procedures and USP/FDA guidelines.
  • 2. Ensuring that the analytical data generated for the cGMP samples are accurate, precise and in compliance with cGMP/FDA and company requirements.
  • 3. Performs laboratory operations with good dexterity, good laboratory techniques, and high degree of accuracy and precision.
  • 4. The QC laboratory related other responsibilities will include, but are not limited to, the following:
  • I.  Prepare reagents, samples, and standards according to procedures.
  • II. Documents testing, observations, deviations, OOS investigation and results clearly and completely.
  • III. Read and understand internal SOPs and analytical procedures (compendia and in-house). Working knowledge of the current USP.
  • IV. Writes standard operating procedures and analytical methods.
  • V. Assures that all laboratory functions are performed in a safe manner, following all relevant company and department safety rules and procedures.  Assures that good housekeeping is maintained in the laboratory and other work places.