Scientist I

Fresenius Kabi USA•Melrose Park, IL

8d•Onsite

About The Position

Oversees the implementation of quality plans and assurance regulations, revises SOPs, supports audits and inspections, and leads the adoption of new regulations to ensure GCP standards are met in clinical trial processes.

Requirements

Possess a B.S. in Chemistry, Biology or related physical science.
1-4 years of related experience in pharmaceutical industry and a familiarity with cGMP and FDA regulations.
Must have hands-on experience and knowledge of chromatographic methods and related chromatography data systems (i.e. Empower).
Must be proficient in Microsoft Office (Word, Excel).
Must be flexible with continually changing projects and priorities.

Responsibilities

Be able to articulate work related issues clearly and effectively to management and peers
Performs accurate routine testing utilizing instrumental methods of analysis (HPLC, TLC, FTIR, pH, UV-Vis) with emphasis on chromatography to meet departmental objectives.
Updates and routes SOPs, MOAs, Specifications through Documentum as delegated by supervisor.
Performs troubleshooting of instrumentation by applying problem solving skills.
Provides guidance to Associate Scientist personnel when necessary.
Documents testing in compliance with Good Documentation Practices
Manages work and time based on departmental priorities using own judgement and objective reasoning.
Performs peer review of data to ensure compliance and accuracy.