The Chemist will performing basic testing of raw materials and finished products, maintenance and calibration of analytical instruments in compliance with cGMP. The position will provide assistance to analytical quality control manager to meet project timelines and improve laboratory compliance.
•Perform routine testing, both wet chemistry and instrumental analysis, according to SOPs, testing methods, protocols, compendia (USP/EP/JP).
•Perform testing of raw materials, APIs, finished products, stability samples and cleaning verification samples.
•Experience with HPLC/GC analysis
•Document laboratory work according to cGMPs and SOPs.
•Troubleshoot, calibrate and maintain instruments as required.
•Prepare and label laboratory reagents, reference standards, or solutions according to SOPs.
•Perform peer review of analytical documentation.
•Follow safety procedures when working in laboratory.
•Understand and comply with cGMPs and other regulations.
•Maintain the laboratory in an organized and neat manner.
•Sampling of controlled materials and managing reference standard inventory.
•Coordinating the shipment of samples to contract laboratories and to clients.
•Other duties as required based upon organizational needs.
•BS degree required, preferred in science degree.
•Familiar with fast paced contract manufacturing environment and be able to work under pressure while maintain high quality.
•Experience working with potent, or cytotoxic materials preferred.
•Working experience with parenteral drug products preferred.
•Industry recognized certifications such as CQA, CPGP, or RAPS are preferred...cont.