Job Description

Job Overview

Performs Analytical chemistry examination testing on raw materials, finished products or stability samples in accordance with approved Standard Operating Procedures (SOPs) and valid methods. This is a safety-sensitive role.

Key Roles/Responsibilities

• Chemical or Physical testing analysis of raw materials, finished products, stability or request samples
• Documenting and submitting all raw data and results in LIMS
• Preparation of reagents for chemical analysis including peer review
• Knowledgeable in compendial (USP/EU) testing requirements and ensuring compliance per FDA 21 CFR

Experience

• Bachelor's degree in chemistry, biology, microbiology or other related science with relevant laboratory coursework is required.
• 1 - 2 years laboratory experience, preferably in a GMP environment

Competencies

• Basic knowledge of laboratory safety practices and PPE
• Basic knowledge of cGMP
• Basic understanding of good documentation practices
• Understanding of compendial testing requirements
• Preferred experience with FTIR, dissolution, UV-VIS, Karl Fischer, pH, wet chemistry techniques, reagent preparation, volumetric solutions.

Physical Requirements

• Lift/move up to 10 lbs. and occasionally 25 lbs.
• Individual may be required to handle hazardous and non-hazardous materials.
• Individual may be required to wear Personal Protective Equipment.
• Not allergic to chemicals or biosubstances found in the laboratory or production facilities.

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