QU-REC-0932236-Job description for Purification Operator A, downstream, September 2025.
Responsibilities:
✓ Carry out production activities with the Clarification area for the distribution of the fractions to be received in stage 9 of the production process of the monovalent influenza antigen bulk.
✓ Perform the start-up, cleaning and operation of the equipment used in stages 9 to 14 of the production process, such as Alfawassermann KII ultracentrifuges and Beckman Optima centrifuges, refractometers, peristaltic pumps, Sartocheck, autoclaves, MAS 100, Climet and laminar flow hoods, in accordance with the operating and cleaning procedures specific to each piece of equipment, following the applicable quality and safety guidelines for each one.
✓ Monitor viable and non-viable particles, CAP, N2, and water sampling, following the current procedures, to ensure compliance with the manufacture of the monovalent influenza antigen bulk with Quality.
✓ Complete records (manufacturing procedures, logbook entries, area identifications, material and product identifications) generated by the Purification process in accordance with the ALCOA quality attributes (Attributable, Legible, Contemporaneous, Original, Accurate) for GMP records.
✓ Request the materials needed to work on time (materials, solutions, cleaning and process supplies).
✓ Track, update and comply with the required training percentage in accordance with the general training matrix (training compliance via iLearn).
✓ Keep your electronic access active (Windows, SAP, Adobesing, Master, as well as access to the equipment used in your work areas).
✓ Responsible use of facilities, equipment, personal protective equipment and tools.
✓ Follow the SMS 2.0 standards (+QDCI, use of visual aids, work standardization, process robustness, continuous improvement, equipment care).
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