Posted on: May 29, 2019 • Category: Manufacturing, Analytical Services
Requires a science degree relevant to the pharmaceutical industry
This position is responsible for performing sampling and testing of packaging components, raw materials, utilities, and products in compliance with site systems/procedures and cGMPs including: •Write analytical test methods and procedures •Review USP/NF, forum, and supplements for applicable changes impacting testing •Perform sampling and testing of packaging components, raw materials, in-process samples, finished products and stability samples. •Perform testing using HPLC, GC, and FT-IR •Validation of laboratory instruments •Validation and transfer of methods •Review and sign-off analytical data and documentation •Qualification, calibration and maintenance of laboratory equipment •Perform out-of-specification/out-of-trend investigations to determine root cause and implementation of CAPAs
Requires a minimum of 5 years of laboratory experience in a GMP regulated industry. Possess a strong understanding of cGMPs and FDA regulations. Requires excellent written and communication skills as well as attention to detail. Able to perform testing, maintenance, and troubleshooting on laboratory instruments to include HPLC, GC, and FT-IR. Validation and method transfer experience preferred. Functional knowledge of Microsoft Office products.