Scientist, Quality Control (2025-017-397) Position Available In Madison, Alabama

Scientist, Quality Control (2025-017-397)

Gannet BioChem Huntsville, AL Job Details Full-time Estimated:

$54.1K – $68.5K a year 22 hours ago Qualifications Gas chromatography

CGMP GLP

Doctoral degree Analytical chemistry High-performance liquid chromatography Data analysis skills Laboratory experience Mid-level Wet chemistry Doctor of Philosophy Computer skills Manufacturing 2 years Communication skills FDA regulations Full Job Description Essential Duties and Responsiblities Recognize OOT/OOS results and appropriately conduct investigation. Responsible for conducting routine and non-routine analysis of in progress 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 established specifications and report any abnormalities. Revise and update standard operating procedures as needed. Perform special projects on analytical instrumentation for manufacturing related problem-solving purposes. Apply knowledge of good manufacturing practices and good laboratory practices daily. Works on complex problems where analysis of situations or data requires an evaluation of tangible and intangible variables. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Act independently to determine methods and procedures appropriately when executing new assignments. Provide data analysis, troubleshooting and problem solving for abnormal results. Provide training to junior analysts. Supports QC release and stability testing. Perform various analyses, such as NMR, HPLC, UV-Vis, GC and other wet chemistry techniques. Maintain accurate and well-organized laboratory records and worksheets. Assist with other projects as assigned. Minimum Qualification Requirements A minimum of 2 years related analytical chemistry experience is required for PhD (4-5 years related experience for MS) in related field. Must have a demonstrated working knowledge of scientific principles, as well as cGMP and cGLP experience. Practical experience in HPLC, GC, UV-Vis and general laboratory wet chemistry techniques required. NMR experience is a plus. Experience in data analysis, troubleshooting and problem-solving skills is a must. Knowledge of FDA regulations and cGMPs for drugs are required. Good oral and written communication skills are required. Good computer and documentation skills are required. Experience with Empower software is required and Topspin software is a plus. Must be well organized and willing to work as part of a team. Must be able to work independently and exhibit flexibility in task management. Physical Requirements Must be able to pass pre-employment drug screening and background check for employment consideration. 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 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.