This position will perform quality control testing for raw materials, product, and environmental samples, according to approved Standard Operating Procedures and cGMP guidelines. Complete testing documentation and data entry as required for procedures and tests performed. Review and/or approve data generated by other analysts in the laboratory. Accountable for following Standard Operating Procedures (SOPs) and ahdering to cGMP guidelines. Select, develop and troubleshoot test methods for quality control testing of raw materials, product, and environmental samples. Write, and oversee the execution of, validation protocols or other special projects for analytical testing to suppport manufacturing activities.Write and revise Standard Operating Procedures according to cGMP guidelines.Prepare written reports, and data summaries, as required by Quality Control management. Use creativity, cGMP guidelines, SOPs, and thorough knowledge of chemistry/biochemistry to obtain solutions to complex problems as directed by QC management. Maintain current knowledge in field of expertise. Perform instrument calibration or qualification according to written procedures. This is a second to third shift position in our Quality Control laboratory.
Thorough understanding of chemical and/or biochemicl test methods is necessary. The individual should have extensive experience with several of the following: HPLC, GC, spectrophotometric assays, immonochemical methods, titration assays, and/or IR spectroscopy. The individual should possess good communication skills, be detail-oriented, and able to work well with others. The individual should be flexible and able to handle multiple priorities. Able to use personal computer, perform dilutions and math calculations, understand and follow instructions, record information, find solutions to practical problems or request assistance.
B.S. or M.S. in Chemistry, Biochemisty, Biological Sciences, Medical Technologist or related science discipline. At least eight years of experience in Chemical/Biochemical testing, including experience in a regulated environment (FDA, EPA, etc). Knowledge of FDA cGMP requirements is an essential pre-requisite for this position
Biotest Pharmaceuticals - 23 months ago