Noven Pharmaceuticals, Inc - Miami, FL
Investigation Specialist (Biotech)
The Quality Control Department is responsible for support of the Manufacturing department and external customers. The primary functions of the laboratory are to test and report results from our Raw Materials, Intermediates, Finished Products and Stability Samples. Laboratory testing encompasses assays performed on raw materials and drug product at various stages to determine product safety and quality.
The Investigation Specialist will be responsible for initiating, investigating, writing, and participating in investigations associated with QC laboratory testing. The Investigation Specialist will be able to conduct interviews with the testing analyst(s) and thoroughly detail findings according to Standard Operating Procedure, to ensure root cause, risk assessment, and corrective and preventative actions are identified and documented within established time frames.
Essential functions are, but not limited to the following:
Competencies:
Education & Experience:
Bachelor degree in Chemistry or related scientific field requiring a minimum of two years of laboratory/industry experience. Excellent technical writing and oral communication skills are required. The individual will also need Laboratory and QA / QC experience in pharmaceutical environment working with raw materials/in-process/finished products/stability. Strong analytical / chemistry experience and knowledge are required.
Experience/knowledge in the following areas:
Excellent written and verbal communication skills; must be organized, motivated and detail-oriented. Ability to interpret complex data sets. Must have ability to work under pressure, overtime, and weekend hours, according to project and/or business deemed necessary.
Work Environment:
A laboratory environment with exposure to chemicals, caustics, fumes, heat, and odors.
Physical Demands:
Visual acuity and manual dexterity required to operate computer. Majority of the time will be spent writing investigations, deviation reports, CAPAs, etc. Additional requirements involve the ability to stand in the laboratory, gathering information and interviewing analysts on specific details related to the investigation.