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POSITION SUMMARY:
⢠Reports to QC Chemistry Supervisor
⢠Individual must use judgment to determine when independent action is appropriate or to contact supervisor for direction.
⢠Individual will assist Associate Scientists and Scientists with assignments.
⢠Duties are of routine nature and are followed according to established standard operating procedures.
⢠Responsible for the timely and accurate support of the Stability program including initiation, sample pulls, sample shipment, inventory tracking, chart monitoring, paperwork preparation, SOP updates and data entry.
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT:
⢠Orders supplies and maintains laboratory stock.
⢠Collects and Tests utility samples
⢠Maintains accurate records of all physical and analytical testing.
⢠Promptly reports discrepancies and out of limits conditions to supervision.
⢠Assures that the correct documentation has been received from Product Release and files documentation properly.
⢠Assures new SOPs are placed in training and returned by deadline.
⢠Conducts Vials Seal Integrity Analyses.
⢠Performs daily calibration of Laboratory Balances.
⢠Performs routine pH analyses.
⢠Performs Visual Inspection and volumes for Finished Product.
⢠Performs sampling and physical release of all Raw Materials and Finished Products.
⢠Prepares and catalogs HPLC, reagents, ACS and Test Solutions.
⢠Responsible for temperature and/or humidity charts for controlled rooms, chambers and cabinets.
⢠Tracking of inventory.
⢠Paperwork preparation and data entry.
⢠Responsible for audit response tracking.
⢠Support the regulatory annual report and Annual Quality report process.
⢠Generate reports as requested by management.
⢠Assumes additional duties and responsibilities as assigned.
REQUIREMENTS:
⢠BS degree in Chemistry or related field.
⢠Associates degree with 1 â 2 years of related experience.
⢠High school diploma with 3 years of related experience.
⢠Basic verbal and written communication skills are necessary.
⢠Ability to perform light to moderate physical labor, at times briefly under conditions of extreme heat, cold and humidity.
⢠Must be able to work overtime as necessary.
⢠Working knowledge of cGMPâs.
