QC Chemist II

DUTIES AND RESPONSIBILITIES This position is responsible for coordinating work activities in specific functional areas of the QC Chemistry laboratory such as Stability, Raw Materials, Finished Product. The position performs planning, organization, work scheduling, data review and release, test/trend reports, investigations and more advanced analytical testing to support the operations. Performs data review and record maintenance to support product release, in-process release, stability program and raw material release. This includes review of data sheets, reports, logbooks, laboratory notebooks, etc. and performing release functions. Performs work scheduling to ensure testing and other activities are performed in a high quality, efficient and timely manner. Performs data analysis and trending and provides summary reports. Assists supervisor with nonconformance investigations. Includes preparation of investigation reports. Participates in internal and external audits. Performs advanced testing and other activities to support product release, nonconformance investigations and qualification of process changes. This includes testing to support process validations, analytical method transfer, method changes, new materials and other special projects. Prepares and reviews reports. Calibrates and maintains analytical equipment as needed. Prepares test systems for annual validations as required. Responsible for authoring and reviewing new/revised procedures and methods. Implements new instrumentation and coordinates project activities. Responsible for coordination of training activities within one or more functional areas. Perform training and mentoring of other laboratory personnel and actively involved in troubleshooting equipment and method issues. May participate in interviews of new personnel. Provides guidance to manufacturing on batch calculations. As delegated, performs monthly safety training and audits. Performs routine laboratory maintenance tasks including organization and cleaning of work areas, checking for expired reagents and standards, disposal of product samples, chemicals and hazardous waste. Performs duties and appropriate functions for QC Chemistry Laboratory Technician I, II, III, Associate Chemist, Chemist I and Laboratory Assistant as required. Follows all laboratory safety and housekeeping procedures. Performs all tasks including testing and documentation in a high-quality and timely manner according to procedures and cGMPs. Performs all tasks effectively in a team environment. Ensures all of the appropriate training has been completed and documented. This includes procedural training, safety and GMP training. Actively involved in initiatives for continuous improvement. REQUIRED EDUCATION/EXPERIENCE/SKILLS Four year college degree in chemistry or related science with at least 5 years analytical laboratory experience or advanced degree in chemistry or related science with at least 2 year analytical laboratory experience. Strong knowledge of Analytical Chemistry principles and concepts. Strong analytical ability and problem solving skills. Knowledge in operation of general laboratory equipment. Knowledge of cGMPs, USP/NF/EP/JP is required. Good computer skills. Experienced with typical office software. Effective oral communication skills. Strong written communications skills. Ability to follow written procedures and document all activities in an accurate and prompt manner. Good interpersonal/group skills. Good organizational skills. Ability to work effectively in a team environment. DEY supports diversity in the work place. We are an Equal Opportunity Employer.