- Perform buffer, media and solution preparation according to cGMP manufacturing control procedures. Disassemble, clean, reassemble and depyrogenate and/or autoclave various fermentation, purification and vaccine formulation apparatuses per appropriate SOP’s. Inventory, requisition, transport and stock chemicals and laboratory supplies on a routine basis.
- Maintain accurate and updated cleaning and use logs, and component accountability logs. Perform manual and automatic labware cleaning. Provide labs with clean, dry, ready-to-use labware in a timely fashion.
- Routinely check and record temperatures and room pressure differential reading. Maintain production areas in a clean, organized, and safe manner. Perform lab cleaning, upkeep, and sanitization duties. Perform daily, weekly and monthly suite cleaning activities per SOP.
- Maintain written, updated, and organized records and complete GMP documents neatly and accurately. Comply with all applicable Standard Operating Procedures, Manufacturing Control Procedures, cGMP’s, safety policies and company policies.
- Train on fermentation techniques and routine performance of CIP of CSC-15. Assist in training new hires in buffer, media and solution preparation.
- May be trained further to assist in antigen fermentation, antigen purification, vaccine formulation, adjuvant manufacturing if need arises and schedules permit. Assist in depyrogenation, equilibration and cleaning of chromatography columns, and other antigen purification and vaccine formulation activities as so trained and directed.
- Contribute to the biennial review or revision of related Standard Operating Procedures and/or Manufacturing Control Procedures.
- Must have good communication and organizational skills, read, write, speak and comprehend English and follow written and verbal instructions. Must be able to stand, walk, lift, and perform repetitive tasks for extended periods of time.
- Must work independently and with minimal supervision on routine assignments for which he/she has been trained.
- Must be able to recognize deviations from accepted practice and notify supervisor.
- Should be competent in typical computer applications such as word processing and spreadsheets. Must be able to organize and prioritize daily tasks.
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