Job Title
Job Responsibilities:
The incumbent must have skills required to organize, develop and motivate the people in his/her area of responsibility, as well as to obtain the cooperation of other functions necessary to fulfill assigned responsibilities. Supervise and train laboratory analysts in the performance of chemical quality control tests in accordance with standard test methods. This includes qualitative and quantitative evaluation of solutions, drugs and commodities. Assure that all products received in the laboratories are logged in, assigned to analysts for testing, reviewed for completeness and accuracy of testing, results compared to standard specification requirements, results documented on the appropriate testing form, form reviewed, signed off and filed. Review testing results and release conforming materials to Production. If results are non-conforming, advise the Manager, Manufacturing Quality Supervisor, and the Production Supervisor and assist in resolving the nonconformance. Conduct investigations into process excursions, procedural exceptions and nonconforming events. Ensure root cause, corrective action preventative action (CAPA), and product impact are thoroughly addressed in investigations. Provide recommendations for action based on procedural requirements, decision flowcharts, and critical thinking. Maintain an adequate stock of reagents, test solutions and standard solutions used in testing and assaying product; assure that the test solutions preparation logbooks are properly maintained.
Key skills:
Maintain current knowledge of all laboratory equipment (Liquid Chromatograph, Gas Chromatograph, Infrared, Flame Photometer, Atomic Absorption, Polarimeter, UV/Visible Spectrophotometer, etc.). A thorough working knowledge of GLP (Good Laboratory Practice), GDP (Good Documentation Practice) and GMP (Good Manufacturing Practices) is required including experience with regulatory agencies including the FDA.
Education and Experience:
Bachelor's degree in Chemistry, Biochemistry, or Chemical Engineering. A minimum of 2 years' experience in a regulated industry (drug/device and FDA preferred), with Quality Control experience required. A minimum of 0-3 years' experience in supervisory/leadership position is preferred. Prior experience in analytical chemical laboratory methodology is required, including methods development, instrumental analysis and technical problem solving and Data Integrity, preferably in the pharmaceutical industry.
