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Form of work- Responsible for conducting routine and non-routine analysis of raw materials, in-process and finished formulations according to standard operating procedures.
- Compiles data for documentation of test procedures and prepares reports.
- Calibrates and maintains lab equipment.
- Reviews data obtained for compliance to specifications and reports abnormalities.
- Revises and updates standard operating procedures as needed. Supports product development as needed.
- Applies knowledge of good manufacturing practices and good laboratory practices on a daily basis.
- Works on problems of moderate scope where analysis of situation or data requires a review of identifiable factors.
- Exercises judgment within defined procedures and practices to determine appropriate action.
- Normally receives general instructions on routine work and detailed instructions on new assignments. Supports QC release and stability testing.
- Assists in performing various analyses, such as HPLC, UV-Vis spectroscopy, particle size determination, and moisture analysis and general wet chemistry techniques.
- Maintains accurate and well-organized laboratory records and worksheets. Executes on assigned tasks following SOPs and GMPs.
- Performs other duties as assigned.
A minimum of a Bachelor’s degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 3 year related experience (which can include lab experience while in school) is preferred. Previous experience in the pharmaceutical industry working in a GMP environment is preferred. Must have a demonstrated working knowledge of scientific principles. Practical experience in HPLC, UV/Vis spectroscopy, and/or moisture analysis is a plus. Good oral and written communication skills are required. Some experience in data analysis is preferred. Knowledge of FDA regulations and cGMPs for drugs and/or device are a plus. Aerosol and pulmonary delivery experience is a plus. Must be well organized and willing to work as part of a team.
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. Huntsville, AL only: Employee must be able to pass drug screening for employment consideration.
