Operation of high throughput automated filling and packaging line for molecular diagnostics products. Initial training will be on immunoassay product lines. Complete batch records and review process for products. Read, understand and follow company and department standard operating procedures. Adhere to policies and procedures to reflect operations; ensure FDA, ISO and related regulatory requirements are consistently met. Update and maintain personal training record electronically.
Experience/Requirements: Two year degree or higher preferred; minimum high school degree or equivalent. Understanding Lean Manufacturing concepts and applications and work experience in a clean room environment, a plus. Must have three plus years related experience in manufacturing. Must have experience in GMP, ISO, or FDA environments; medical device manufacturing preferred. Computer experience with some proficiency with MS Office (Word, Excel). Strong attention to detail; a team player & perform well under deadlines. Prioritizes own work to complete assignments on a timely basis. Acts independently as appropriate. Able to work in a team environment.