QA Chemist

Penn Life seeks QA Chemist in Langhorne, PA to conduct core quality system audits including

investigations of any deviations, change control and CAPA; perform quality assurance analysis of

raw materials, in-process materials; perform stability analysis; conduct identification tests of raw

materials as instructed using UVNis, Spectrophotometer, NIR etc. and perform assay of finished

products using HPLC and Titrimetry; perform scientific and analytical testing of products for

stability & prepare stability study reports to ensure robustness of product and validation of shelflife; compile scientific research and development reports, batch records, PDR and ANDA

submissions in compliance with 21 CFR and prepare technical reports on compliance with 21 CFR

regulations in manufacturing/packaging processes; develop and design IQ/OQ/PQ protocols

according to 21 CFR for all equipment as per VMP; draft SOPs; conduct final inspections of Batch

Manufacturing Records for product release; test parameters for tablets including hardness testing,

friability testing, disintegration and thickness studies etc. among others. Bachelor's degree or

foreign equivalent Chemistry/Biochemistry/Pharmacy or related and 3 years relevant work

experience required. Multiple positions open.

Mail resume to HR Manager, Attn: QAC,

Penn Life Sciences LLC, 38 Cabot Blvd. E, Langhorne PA 19047.