QC Lab Analyst I - Monday - Thursday 2nd Shift (2:00pm-12:30am)

About the role

The QC Analyst I position is responsible for all daily laboratory testing of raw materials, in-process, and finished products. In addition, this position is responsible for providing support for routine laboratory tasks and analysis, including but not limited to environmental monitoring, equipment calibrations/verifications, raw material sampling, laboratory/production process testing including chromatography analysis.

Responsibilities

• Perform chemical testing using analytical instrumentation and wet bench techniques including pH, Viscometers, FTIR, UV-VIS, TOC, Gas Chromatography, and Liquid Chromatography
• Minor troubleshooting of testing and instrumentation as necessary and writing of minor laboratory investigations
• Aids in completing all Laboratory investigations, including OOS investigations, as required by management
• Sampling of raw materials for QC Lab testing, as well as performing the required testing for raw material release
• Sampling and performing analysis for Site Environmental Monitoring
• Performs routine maintenance, calibrations, and verifications of QC Laboratory equipment
• Familiar with Quality GMP documentation (hard copy and electronic) of testing results and assurance of laboratory data integrity
• Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and keep proper documentation in compliance with SOPs
• Support QC audit readiness with understanding of FDA and ISO regulations and requirements
• Support on-time performance in the QC lab against the Production and laboratory schedules
• Maintain a safe, clean, and organized environment for all QC areas
• Employ sound and compliant laboratory techniques and logic per industry standards (e.g., FDA, USP/NF, ISO, ANSI) and internal and customer requirements
• Review QC Lab testing and processes for adherence to lab and site SOPs
• Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices

Requirements

• Associates Degree with 5+ years of laboratory experience (chromatography experience preferred)
• Bachelor’s degree in Chemistry or related field with 1-2 years of experience

Education

• Associates Degree with 5+ years of laboratory experience (chromatography experience preferred)
• Bachelor’s degree in Chemistry or related field with 1-2 years of experience

Experience

• Knowledge of analytical instrumentation (pH, Viscosity, FTIR, UV-VIS, etc.)
• Experience working in an ISO or FDA-regulated environment preferred

Skills & Abilities

• Computer Skills
• Computer Literacy
• Experience with Microsoft Office, LIMS, Empower, and other software
• Laboratory Skills
• Wet Bench Testing
• Standard Preparation
• Balance Use/Weighing
• Microbiology Techniques