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

Job Description:

Essential Duties and Responsiblities Responsible for conductingroutine and non-routine analysis of raw materials (sampling ifrequired), In-Process/Reaction intermediate and Finishedformulations according to standard operating procedures. Compilesdata for documentation of test procedures and prepares reports.

Calibrates and maintains lab equipment. May develop testingmethods. Reviews data obtained for compliance to specifications andreports abnormalities. Revises and updates standard operatingprocedures as needed. May perform special projects on analyticaland instrument problem solving. Applies knowledge of goodmanufacturing practices and good laboratory practices daily basis.

Works on complex problems where analysis of situations or datarequires an evaluation of intangible variables. Exercisesindependent judgment in developing methods, techniques andevaluation criteria for obtaining results. Acts independently todetermine methods and procedures on new assignments. Provides dataanalysis, troubleshooting and problem solving. Provides training tojunior analysts. Supports QC release and stability testing.

Performs various analyses, such as NMR, HPLC, UV-Vis spectroscopy,GC, particle size determination and moisture analysis. Maintainsaccurate and well-organized laboratory records and worksheets.

Assists with other projects as assigned. Recognize OOT/OOS resultsand appropriately conduct investigation. Minimum QualificationRequirements A minimum of a Bachelors degree in a scientificdiscipline is required. PhD is preferred. A minimum of 8 yearsrelated experience is required or advanced degree (MS with aminimum of 5-6 years or PhD with a minimum of 0-2 years) in relatedarea with experience. Must have a demonstrated working knowledge ofscientific principles. Practical experience in HPLC, UV/Visspectroscopy, GC, general laboratory wet chemistry techniquesand/or moisture analysis is required. Experience in data analysis,troubleshooting and problem-solving skills is a must. Knowledge ofFDA regulations and cGMPs for drugs and/or device are required.

Experience in data analysis, troubleshooting and problem-solvingskills is required. Good oral and written communication skills arerequired. Good computer and documentation skills are required.

Experience with Empower software is required. Must be wellorganized and willing to work as part of a team. Must be able towork independently and flexible. Must be flexible to work on 2ndshift (if required on temporary basis). Physical RequirementsEmployees must be able to lift or handle objects greater than 25pounds to perform certain duties essential to the job function.

Employees may be required to perform tasks essential to the jobfunction in areas that require the use of hearing protectiondevices. Performance of tasks essential to the job function mayrequire the employee to work directly with, handle, or otherwisecome into contact with chemicals or pharmaceutical agents.

Employees must be able to wear a respiratory protection (filteringfacepiece, 1/2 face, full-face, or powered air purifyingrespirator, supplied air, or self contained breathing apparatus)for certain tasks essential to the job function. Employees must beable to maneuver themselves under 30 inch clearances. Employeesmust be able to able to accurately detect color and have 20/20vision (with/without corrective lenses). Employees may be requiredto enroll in a medical surveillance program based on the potentialexposure to certain health hazards encountered as a result of theirjob function. Employee must be able to pass drug screening foremployment consideration.