Quality Control Laboratory Technician

Duration : 9 monthsPrimary Duties:Execute routine in-process, drug substance, and stability test methods.Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, SoftmaxPro, Charles River Endoscan, MODA, and Empower).Maintain lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal).Responsibilities: Job Function and Description:Demonstrate a functional understanding of a laboratory setting and Standard Operating Procedures (SOP’s).Work within laboratory environment for extended periods of time, conducting facility monitoring (i.e., Environmental Monitoring and Critical Utility Monitoring) and product tests, reviewing data, maintaining laboratory materials and instruments and other laboratory functions as required.Complete all testing, including special project and protocol testing in a timely and appropriate manner.Maintain data integrity and ensure compliance with company SOP’s, specifications, and cGMP regulations.Support low risk deviations, CAPA’s and change controls within the electronic Quality Management System.Initiate and own laboratory investigations.Occasionally participate in department problem-solving.Author minor revisions to existing SOP’s.Receives general instructions on routine work and detailed instructions on new assignments.May be required to work overtime or be assigned to a different shift as needed.May perform equipment maintenance and calibrations as required.Complete mandatory training within required timeframe.Perform other duties as assigned.Education and Experience RequirementsBachelor’s or master’s degree in any Life Sciences with relevant laboratory coursework.1+ years of relevant experience.Previous experience in a regulated environment preferred.Laboratory instrumentation understanding or experience preferred.Must be able to communicate effectively with managers and peers.Must be able to read, write, and converse in English.Must have basic computer skills. General use of word processing, spreadsheets, databases, etc. for the purposes of work execution, training, performance management, and self-service. Good interpersonal skills and able to work effectively and efficiently in a team environment.Knowledge of cGMP manufacturing preferred.Knowledge of basic chemical, biological and/or microbiological safety procedures preferred.Must display eagerness to learn and continuously improve.Key Skills, Abilities, and Competencies:QC Analytical Skill Set – HPLC, UPLC, UV-Vis, Appearance, Concentration, pH, CE, Osmolality, TOC, strong micropipetting skillsQC Bioassay Skill Set – ELISA’s, Cell Maintenance, Cell-Based Assays, plate readers, Gels, icIEF, Aseptic Technique, strong micropipetting skills, biosafety cabinetsQC Micro Skill Set – Endotoxin, Bioburden, Environmental Monitoring, Manufacturing Cleanrooms, Aseptic Technique, Critical Utility systems