QC Analyst II

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 position.

Key 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

Competencies

• Good understanding of laboratory safety practices and PPE
  • Expectation of zero safety observations
• Good understanding of cGMP
  • Minimal to no laboratory errors are expected.
• Good understanding of good documentation practices
  • Minimal corrections/errors expected.
• Good understanding of compendial testing requirements
  • Additional understanding of international compendiums such as EP
• Expected to train other analysts.
• Minimal supervision necessary from management.
• Expected knowledge of balance, FTIR, dissolution, UV-VIS, Karl Fischer, pH, wet chemistry techniques, reagent preparation, volumetric solutions, able to handle independent HPLC testing such as cleaning validation, Assay, Blend Uniformity, Impurity Analysis, Dissolution, Content Uniformity.
• Able to perform assigned task from start to finish independently without error. Including standard, sample, and reagent preparation through data processing and submission.

QUALIFICATIONS

Experience

• Bachelor's degree in chemistry, biology, microbiology or other related science with relevant laboratory coursework is required.
• 2 years laboratory experience, preferably in a GMP environment
• Wet Chemistry testing, Balance, Dissolution, FTIR, KFM, UV/Vis, Titrations, Viscosity, PSD testing, pH, conductivity
• Strong written, verbal, and interpersonal communication skills
• Proficiency with computer software such as MS Word, Excel, or PowerPoint

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