USA Quality Lab Associate II

Summary: This section focuses on the main purpose of the job in one to four sentences. Conduct biological chemical and physical analyses on pharmaceutical products and medical devices through all stages of the manufacturing process from incoming raw materials to finished goods and environmental monitoring programs. Essential Duties and Responsibilities: 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 analyses on raw materials initial in-process and final products and samples collected from the environmental monitoring programs at manufacturing under minimum supervision. Serve as Mentor to Quality Laboratory Associate (QLA) I positions. Provide training and work direction for QLA I positions as required. Perform review of test data which includes overall documentation practices. Perform release functions in LIMS or other computerized systems. Use sophisticated laboratory instrumentation and computer systems to collect and record data. Perform advanced biological and chemical 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. Qualifications: 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. Proficient in wet and instrumental methods of analyses. Advanced laboratory skills basic knowledge of statistical method. Strong technical problem solving skills. Ability to handle multiple tasks concurrently and in a timely fashion. Computer literate. Must be able to communicate effectively with supervisors and peers. Must demonstrate effectiveness in ability to train others empowerment leadership results orientation and task completion. Education and/or Experience: Include the education and experience that is necessary to perform the job satisfactorily. Bachelors Degree in Chemistry or Biological Sciences with Analytical Chemistry or Laboratory coursework with 2-5 years experience or Masters Degree in Chemistry or Biological Sciences with 0-3 years experience