Chemist II/III - Quality Control - Remote

Overview

This Chemist is needed to join as part of the Quality Control team and the appointed candidate will perform analytical testing on raw materials and finished goods to support product release in a GMP/GLP-regulated environment.

In Short

• The incumbent works as a team member in Pharm QC within raw materials or finished goods and is responsible for all analysis for product release.
• Responsibilities include the preparation, analysis, and result calculation for all analytical sample types submitted to Pharmaceutical QC as assigned.
• Adherence to approved test methods and SOPs and proper documentation of laboratory raw data onto approved forms.
• Plan for and respond to the analytical needs of the laboratory to ensure daily production schedules are met.
• Ensure proper sorting and disposal of analytical sample solutions that are hazardous waste, and the chemical cleanliness of all work areas.
• Assists weekly in laboratory supply and reagent inventory. Ensure secondary tasks assigned are monitored and completed in a timely manner.
• Critical understanding of proper and thorough laboratory investigations.
• Support QA Operations as required for laboratory investigations.
• Continuous improvement and assessment of laboratory practices to eliminate over-processing of data.
• Continuous review of current SOPs and other documentations to ensure compliance to regulatory requirements.
• Adhere to GMP and/or GLP standards as required for daily operations.

Requirements

• BA / BS in a related scientific field such as biology, chemistry, microbiology, or biochemistry.
• 3+ years laboratory experience, preferably in a Pharmaceutical chemistry laboratory.
• The incumbent should be proficient in the understanding, planning, and execution of laboratory Standard Operating Procedures relating to instrument use, sample analysis, document generation and control, personal safety, and environmental safety.
• Knowledge of FDA regulations (or similar regulated environment) to include Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
• Basic computer skills are required.
• Proven, effective written and verbal communication skills.
• Mastered skills in the use of a wide range of analytical instruments and devices for the analysis of pharmaceutical substances and formulations are required. The incumbent should have the necessary experience and background to develop, create or revise standard operating procedures or test methods. Analytical instrument experience required includes the following:
• HPLC
• GC and/or Headspace GC
• Karl Fisher
• pH
• UV-Vis, AA, ICP-MS and Particle Size Distribution (Malvern 3000) is a plus
• Experience with Empower 3 processing software is a plus.

Benefits

• Details about benefits are not provided in the job description.