Associate Scientist, Quality Control (2025-017-397)

Location: Huntsville
Posted on: June 23, 2025

Job Description:

Essential Duties and Responsiblities Responsible for conducting routine and non-routine analysis of raw materials (sampling if required), In-Process/Reaction intermediate and Finished formulations according to standard operating procedures. Compiles data for documentation of test procedures and prepares reports. Calibrates and maintains lab equipment. May develop testing methods. Reviews data obtained for compliance to specifications and reports abnormalities. Revises and updates standard operating procedures as needed. May perform special projects on analytical and instrument problem solving. Applies knowledge of good manufacturing practices and good laboratory practices daily basis. Works on complex problems where analysis of situations or data requires an evaluation of intangible variables. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Acts independently to determine methods and procedures on new assignments. Provides data analysis, troubleshooting and problem solving. Provides training to junior analysts. Supports QC release and stability testing. Performs various analyses, such as NMR, HPLC, UV-Vis spectroscopy, GC, particle size determination and moisture analysis. Maintains accurate and well-organized laboratory records and worksheets. Assists with other projects as assigned. Recognize OOT/OOS results and appropriately conduct investigation. Minimum Qualification Requirements A minimum of a Bachelors degree in a scientific discipline is required. PhD is preferred. A minimum of 8 years related experience is required or advanced degree (MS with a minimum of 5-6 years or PhD with a minimum of 0-2 years) in related area with experience. Must have a demonstrated working knowledge of scientific principles. Practical experience in HPLC, UV/Vis spectroscopy, GC, general laboratory wet chemistry techniques and/or moisture analysis is required. Experience in data analysis, troubleshooting and problem-solving skills is a must. Knowledge of FDA regulations and cGMPs for drugs and/or device are required. Experience in data analysis, troubleshooting and problem-solving skills is required. Good oral and written communication skills are required. Good computer and documentation skills are required. Experience with Empower software is required. Must be well organized and willing to work as part of a team. Must be able to work independently and flexible. Must be flexible to work on 2nd shift (if required on temporary basis). Physical Requirements Employees must be able to lift or handle objects greater than 25 pounds to perform certain duties essential to the job function. Employees may be required to perform tasks essential to the job function in areas that require the use of hearing protection devices. Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents. Employees must be able to wear a respiratory protection (filtering facepiece, 1/2 face, full-face, or powered air purifying respirator, supplied air, or self contained breathing apparatus) for certain tasks essential to the job function. Employees must be able to maneuver themselves under 30 inch clearances. Employees must be able to able to accurately detect color and have 20/20 vision (with/without corrective lenses). Employees may be required to enroll in a medical surveillance program based on the potential exposure to certain health hazards encountered as a result of their job function. Employee must be able to pass drug screening for employment consideration.

Keywords: , Birmingham , Associate Scientist, Quality Control (2025-017-397), Science, Research & Development , Huntsville, Alabama