Sr. Quality Control Analyst (2 x openings) in Piscataway, NJ
Develop, review and implement manufacturing QA and safety guidelines, regulatory submissions for drug products. Analyze, evaluate and test drug product quality to ensure compliance with SOPs and cGMP. Oversee manufacturing related QA operations and performance. Work with manufacturing and R&D department to ensure that drug products are developed and produced according to applicable regulations. Research, evaluate and interpret complex biological data pertaining to ANDA & new NDA. Req: Master’s degree or equiv. in Pharmaceutical science, Biology, Chemistry, or related field. Familiar with US regulatory submission (ANDA, NDA, BLA, etc) & QA procedures and FDA/ICH regulations related to generic & new drug development in pharmaceutical industry. In-depth knowledge of drug product quality control and drug testing technology. Send resume to Aucta Pharmaceuticals. Inc, 71 Suttons Lane, Piscataway, NJ 08854