Position Summary: Perform laboratory testing and release/rejection of raw materials, intermediates and finished products utilizing clinical chemistry, immunoassay, analytical and microbiological methods and automated systems for testing at the Middletown site. Assure technical correctness of all testing/value assignment functions to ensure products comply with established internal and external requirements required to maintain consistent product performance and quality in the field.
Major Responsibilities: Perform laboratory analysis on products/materials. Evaluate data and prepare technical summaries and supporting reports when necessary for Product release, assessing stability, facilitating complaint investigations, Effecting raw material release, Facilitating value assignments, Supporting Advanced Manufacturing and other Technical Service groups. Prepares samples for testing and test and release products in accordance with written procedures. Schedules testing to meet departmental and plant commitments. Troubleshoots test procedures and/or instruments when problems arise, determines appropriate course of action. Evaluates analytical results and determines conformance to specification; identifies deviations and trends, and out of specification events. Maintains instruments/equipment in accordance with manufacturers' labeling and in-house audit and calibrations procedures. Prepares data summaries and/or reports for technical input; writes and reviews departmental procedures. Maintains all required records/logs in accordance with procedures and GMP; maintains working laboratory inventory. Trains laboratory personnel on lab procedures and operations of instruments/equipment. Other laboratory functions as deemed necessary to support the business needs of the company. Minimum Requirements/Qualifications: BS or BA degree in Biology, Chemistry, Medical Technology or related field with 3 years of laboratory experience. Required area of experience in Analytical Chemistry, Immunoassay, Hematology, Coagulation, Microbiology or Clinical Chemistry. Experience may be substituted for degree in relevant field. Physical Requirements: Normal laboratory/office environment. Position may require frequent communication and walking to other areas in which designated PPE will be required. Position will require sitting and standing. Employee may occasionally lift and/or move up to 45 pounds. Non-Negotiable Hiring Criteria: Knowledge of clinical laboratory instrumentation with strong troubleshooting capabilities. Must be proficient in analytical testing techniques and possess strong troubleshooting capabilities. Ability to organize data for presentation and prepare reports when required. Ability to lift items up to 45 lbs. Knowledge of GMP and ISO requirements Must be knowledgeable of network and Microsoft Office computer applications, i.e. Word and Excel Must be well organized and able to handle multiple tasks with multiple priorities. Must be flexible and able to work overtime or staggered shifts other than normal working hours Must have excellent oral and written communication skills. Ability to interact with all departments and occasional contact with outside sources
