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Analytical HPLC GMP Chemist
Apex Life Sciences is currently seeking an experienced Chemist. The ideal candidate is someone with 2+ years pharma exp. with HPLC, GC, and AA. UPLC would be a plus. Empower would be a plus.
Validate methods for various analytical techniques.
Draft and review technical documents supporting development and release such as method validation/verification protocols and reports, and testing data sheets.
Manage and perform analytical testing of samples supporting incoming raw materials, in-process production, finished product and stability samples.
Utilize analytical instrumentation such as FTIR, HPLC, GC, AA, and UV/VIS and have a scientific understanding of these techniques.
Compile data and perform trending studies on raw materials and drug product.
Perform instrument and method troubleshooting as needed.
Perform investigations on studies that have unusual results, and on out-of-trend and out-of-specification results.
Ability to identify and learn new analytical techniques and equipment without supervision.
Write, review, and update standard operating procedures and department policies as needed.
Perform all activities in compliance with cGLP/cGMP requirements.
Bachelor’s degree in Chemistry or related scientific discipline with approximately 3 - 5 years of relevant Analytical Chemistry experience; or an Associate’s degree with approximately 6 – 8 years Analytical Chemistry experience; preferably in QC, in the pharmaceutical industry.