- Use proper aseptic technique while performing tasks in the Grade A/B areas to include: bulk formulation, vial filling, routine and non-routine aseptic interventions; operating filling and auto loading equipment using automated control systems, unloading of autoclaves and management of sterilized components.
• Operate processing equipment in accordance with SOPs, in all classified areas (Grade A/B/C).
• Actively participate in troubleshooting processes and equipment problems as well as assisting the supervisor in completing all necessary paperwork associated with investigations, deviations and remarks.
• Use proper aseptic technique while performing tasks in the Grade A/B areas to include: filling line, routine aseptic interventions (pulling of samples, EM monitoring & clearing downed vials), non-routine aseptic interventions (filler setup, needle changeout), operating filling and auto loading equipment using automated control systems; perform automatic weight checks; assist with and performs non-routine interventions without compromising aseptic environment.
• Actively participate in the creation and revision of batch records, standard operating procedures, protocols, and all other GMP documents.
• Troubleshoot process equipment and interact with maintenance personnel
• Demonstrate proficiency as outlined in training requirements for equipment systems and position.
• Responsible for loading and unloading materials, labeling according to SOPs, assembling valves, connectors, and other equipment and tools using Aseptic technique.
• Recognize and report deviations or potential issues immediately to the management team.
• Perform all job responsibilities in compliance with applicable regulations, guidelines, policies, standard operating procedures, and industry practice and Industrial Excellence initiatives.
• Communicate and report status of equipment maintenance related issues to the area supervisor / manager, and assist with actions necessary to resolve issues.
• Work on any assignment as directed.
• Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, companies standard operating & safety procedures, and industry practice and Industrial Excellence initiatives.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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