Address
Form of workThe Sr. Research Associate - Quality Control (Raw Material Supervisor) is responsible for conducting routine and non-routine analysis of raw materials (sampling if required), 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 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 on a daily basis.
Essential Duties and Responsibilities
• Works on extremely 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, particle size determination and moisture analysis.
• Maintains accurate and well-organized laboratory records and worksheets.
• Assists with other projects as assigned.
• Will be responsible for supervision activities of other junior Quality Control Analysts.
• Coordinate/ present sampling and testing schedule to material management team
• Recognize OOT/OOS results, and appropriately conduct investigation
Minimum Qualification Requirements
• A minimum of a Bachelors degree in a scientific discipline is required.
• Equivalent experience may be accepted.
• A minimum of 8 years related experience is required.
• A minimum of 5 years experience in the pharmaceutical industry working in a GMP environment is required.
• Previous supervisory experience is a plus.
• Must have a demonstrated working knowledge of scientific principles.
• Practical experience in HPLC, UV/Vis spectroscopy, 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.
• Must be well organized and willing to work as part of a team.
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. Huntsville, AL only: Employee must be able to pass drug screening for employment consideration.
