Position: Effective Date: ASEPTIC FILLING OPERATOR Aug 2010 Reports To: Aseptic Shift Supervisor Page 1 of 2 Department: Production JOB SUMMARY: Therapure Biopharma Inc. is an integrated biopharmaceutical company that provides contract manufacturing services for the client, development, manufacture, purification, and packaging of therapeutic proteins. The Aseptic Filling Operator will interact with aseptic filling equipment for the washing, sterilizing and aseptic filling. Under the guidance of a Shift Supervisor, is responsible for set-up, operation and sanitation of all production/filling equipment and facilities. This position will follow GMPs/cGMPs, SOPs and all company policies/regulations. MAJOR RESPONSIBILITIES: Performs all duties according to the SOPs and GMPs/cGMPs and all other established safety standards and company policies. Operates , assembles, disassembles, cleans and sterilizes the following aseptic manufacturing equipment: Parts Washer Vial Washer Filter Integrity Tester (Pre & Post) Depyrogenation Oven Autoclave for decontamination and terminal sterilization Filler and Stopper Machine Capper Steriles filling operations in Class A/B clean rooms. Maintains housekeeping standards in the aseptic manufacturing area. Documents and records all necessary information/data as per SOPs and GMPs/cGMPs requirements (i.e. observations, test results), following Good Documentation Practices. Notifies the Shift Supervisor or higher in the event that a product defect or other serious problem occurs. Checks contents of filled containers and document result as per SOP. Participates in filling operations in the pilot plant. Performs any other production duties as assigned by Supervisor/Manager. Works according to various shifts scheduled MINIMUM QUALIFICATIONS: TECHNICAL KNOWLEDGE/EXPERIENCE Minimum secondary school diploma. Pre-employment medical and medical re-examination performed every 2 years will be required as per Therapure’s SOPs Mathematical ability, e.g. decimals, addition, subtraction, problem solving. BEHAVIORAL: Demonstrated ability to apply the following behavioral competencies on the job: Goal Orientation: Energetically focusing efforts on meeting a goal, mission or objective Teamwork: Working effectively and productively with others Flexibility: Agility in adapting to change Planning/Organizing: Utilizing logical, systematic and orderly procedures to meet objectives Written Communication: Writing clearly, succinctly and understandably. Position: Effective Date: ASEPTIC FILLING OPERATOR Aug 2010 Reports To: Aseptic Shift Supervisor Page 2 of 2 Department: Production PREFERRED QUALIFICATIONS: Experience in sterile filling an asset. Preferred production experience within a GMP environment. Must be able to lift approx. 25 lbs. Able to work within a team or independently. Detail Orientated. Punctual, alert, and a good sense of urgency and accountability. Confident in decision making, communicating issues and new ideas. Flexible to production changes. Eager to take on new challenges.
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