Chemical Operator
Current♣ Understand and comply with current SOP and GMP requirements relevant to the position♣ Established aseptic gowning Grade A qualification in clean room environment ♣ Responsible for execution of bulk product batch processing, inclusive of all pertinent activities performed in support of the actual batch making♣ Demonstrate aptitude and capability to perform multiple task at same time following manufacturing procedures to process bulk product made right the first time ♣ Maintain professional, courteous, and effective communication with all co-workers, customers, and contractors in the execution of all job functions ♣ Responsible for reviewing production records for compliance iso13485 medical devices. ♣ Sets up & operates equipment such as scales, mixers, pumps, CIP units, tanks, and material handling equipment♣ Maintains accurate records, i.e., log books, raw material inventories, reconciliations and batch records♣ Moves raw material as required for mixing, weighing and storage♣ Weighs all chemicals to prepare cleaning solution batches and on a limited basis, production batches designated by the department♣ Performs acid/base pH adjustments as required by batch or as instructed by QA lab♣ Transfers finished batches to specified area for further processing♣ Adheres strictly to cGMPs and SOPs to ensure the quality and integrity of products♣ Performs preventative maintenance tasks on compounding equipment, such as tanks, mixers and pumps as required or as instructed by supervisor or designee
