Quality Assurance Associates

Quality Assurance Associates (Newtown, PA) - Review and verify the analytical data for Raw materials, in-process materials, finished products and stability samples using HPLC/UPLC and approved Method of Analysis (MOAs); Analyze, design, and develop quality system elements including Deviations, CAPA management systems and Change controls in compliance with cGMP and FDA; Prepare and initiate change controls to revise the SOP's; Conduct the investigations for reported Out-of-Specification (OOS)/Out-of-Trend (OOT); Review batch manufacturing records (BMR's) and support disposition activities; Prepare Annual Product Quality Reviews (APQRs) and QMS metrics for management review and maintain laboratory instruments in compliance with cGMP/cGLP and applicable FDA requirements. Must have a Bachelor's degree in Chemistry or Pharmaceutical Science plus 1 year experience in job offered. Require skills and knowledge of MOA, Change Control, OOS/OOT, batch manufacturing records/BMRs, APQR, CAPA**.** Submit rsum referencing job code RAD005 to HR, KVK-Tech, Inc., 110 Terry Drive, Suite 200, Newtown, PA 18940.