This section focuses on the main purpose of the job in one to four sentences. Conduct biological, chemical and physical analysis on pharmaceutical products (biologic and drugs) and medical devices through all stages of the manufacturing process from incoming raw materials to finished goods, and environmental monitoring programs. This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. - Conduct critical biological, chemical and physical analysis on raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at a manufacturing facility. Work under minimum supervision. - Use sophisticated laboratory instrumentation and computer systems to collect and record data. Perform advanced assays requiring precise analytical skills and understanding of biology and chemistry principles. - Complete all testing, including special project / protocol testing in a timely and appropriate manner. - Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. - Investigate deviations and write exception documents. - Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality. - Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs. - Perform equipment maintenance and calibrations as required. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Ability to handle multiple tasks concurrently, and in a timely fashion. Computer literate. Must be detail oriented, conscientious and have high reading comprehension skills. Must have basic understanding of laboratory instrumentation. Must be able to communicate effectively with supervisors and peers. Include the education and experience that is necessary to perform the job satisfactorily. Bachelors Degree in Chemistry, or Biological Science with Analytical Chemistry or Laboratory coursework and 0-2 years experience Perform medical laboratory tests for the diagnosis, treatment, and prevention of disease. May work under the supervision of a medical technologist. Requires formal training and may involve scientific analysis or process development. Work does not require routine inspection, testing, grading, sorting, sampling, or weighing of either raw materials or processed products. See staffing description below for comparison.