Over Night QA Specialist Quality Assurance Union County, NJ, US + Added - 21/08/2024 Apply for Job **_Our client, a leading contract development and manufacturing organization (CDMO), is seeking a QA Specialist to join their growing team. This is a great opportunity to contribute to the development and commercialization efforts._** **Location:** Union County, NJ **Schedule:** Sunday-Wednesday9:00PM-8:00AM **Key Responsibilities:** + Ensure compliance with applicable SOPs in manufacturing, materials storage, and analytical labs. + Conduct weekly GMP walkthroughs independently, with periodic walkthroughs alongside Quality Management Personnel. + Possess strong written and verbal communication skills, with the ability to critically evaluate and interpret quality event investigations. + Apply knowledge of quality risk management strategies and demonstrate the ability to continuously improve the QMS and manufacturing/testing operations. + Handle the initial processing and review of quality events (QEs) identified on the shop floor. + Conduct daily reviews of all logbook entries in the manufacturing and analytical areas of the facility. **Education/Experience:** + Bachelor’s degree in a STEM field, or an equivalent combination of education and experience. + 2+ years of experience working within a GMP environment. + Familiarity with pharmaceutical manufacturing and analytical lab operations. + Work in a variety of settings, including manufacturing cleanrooms (aseptic gowning validation required), quality control analytical testing labs, materials storage facilities, and office environments. + In-depth understanding of FDA-regulated pharmaceutical manufacturing and testing operations. \#INDBH \#LI-DNI We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.