Summary or Objectives: Potency validation analysts are responsible for designing a project outline and performing all necessary tests required for a stability indicating assay (SIA) validation method. Testing included in the SIA validation are, but not limited to, linearity, accuracy, precision, robustness, ruggedness and forced degradation of validation samples. The potency validation analyst will be knowledgeable in liquid chromatography and sample preparation. They will know how to run and troubleshoot ultra high-performance liquid chromatography (UHPLC) instrumentation, record, and interpret results. They should be knowledgeable with Excel, PowerPoint, and Word Document. Analysts will be able to comprehend sample preparation concerns and adjust techniques appropriately. They will know how to decide which column, mobile phase, buffers, etc. to use for any given sample. They will know to maintain the instrument in good working order, preform required maintenance and determine if major repairs are needed. They will know how to follow methods and how to store solvents, standards, and columns so as to optimize the chromatography. Analysts will need to have good communication skills, be detail oriented and have the ability to organize and prioritize assigned projects. Being a good team member is essential to the success of this position.
1. They will be proficient in operation of the UHPLC instrument, which shall include:
a. Turning on and preparing the instrument for use.
b. Checking that the UHPLC instrument is running properly, correct mobile phase solvent is present in an adequate amount for the prepared analysis, sample vials are placed into the correct vial positions, the correct column is selected for the analysis, preparing columns for the intended analysis, and ensuring that a solvent waste container is present and sufficient in volume to collect the projected amount of waste produced during the analysis.
c. Running system suitability and interpreting the results.
d. Cleaning off columns and preparing the instrument to shut down.
e. Troubleshoot instrumentation and sample preparation issues, as they arise.
2. The analyst will obtain a standard/sample for the SIA validation and start designing the validation project:
a. Research the analyte(s) for hazardous concerns, pKa, solubility, published chromatographic methods, internal UHPLC methods, light sensitivity, etc.
b. Prepare a dilution scheme for the analyte(s) for all aspects of the SIA validation process.
c. Develop a chromatographic method for the analyte(s) that meets all system suitability requirements.
3. Execute SIA validation project:
a. Perform all analyses required for the validation project.
b. Record, interpret, and workup data acquired from validation analyses.
c. Insert summary of data into report template and add pertinent information as needed/required.
d. Organize all raw data and reporting into project folder for review.
4. Laboratory skills:
a. Analysts are responsible for keeping their work station clean, uncluttered and neat.
b. Understanding how to properly use and clean chemical glassware.
c. Analysts are responsible for storing standards, samples and mobile phase solvents under the correct storage conditions when they have completed using them.
d. Analysts are responsible for handling DEA controlled substances according to the protocols set up by the Compliance Officer.
e. Analysts are responsible for wearing the appropriate garments in the lab including shoes, protective eye glasses, gloves when necessary, and to exercise caution when handling chemicals and samples. They are required to be familiar with the safety sheets at each lab station.
f. Analysts are responsible for knowing how to contain and clean up spills of any kind. They are responsible to help anyone who may be involved in a splash or spill who may require assistance, to contain the spill, go to the emergency station for eye wash or shower and to summons help, if needed. They must report all splashes and/or spills to their supervisor, as soon as possible.
g. Analysts are required to obey all signage, written policies, SOPs (standard operating procedures), and management instructions at all times.
Role: Validation Analyst I (entry level)
Location: Castle Rock,
Apply for this job now.