Our client, a global joint preservation company, has an immediate opening for a Quality Control Analyst II. This role is primarily responsible for the activities and procedures which are required to sample and test raw materials, work-in-process samples, finished goods, and stability samples under cGMP conditions.

Responsibilities:

• Test incoming raw material according to USP, EP, or ACS Reagent Index
• Test in process and release manufacturing samples, stability samples, and Engineering/R&D samples using the following instrumentation/techniques:
  • HPLC
  • GC & GC/MS
  • UV/Vis Spectrophotometry
  • FTIR Spectrophotometry
  • Auto & Manual Titrations
  • Freezing Point & Vapor Pressure Osmometry
  • Absolute Viscosity using Brookfield Cone/Plate Viscometer
  • Intrinsic Viscosity using Ubbelohde Tube and Dilute Solution Viscometer
  • pH Meter
  • TOC Analyzer
  • Conductivity Meter

• Complete required documentation for all work activities according to Good Documentation Practices
• Research and optimize Test methods according to accepted industry best practice
• Report procedural deviations and nonconformances to management
• Perform other duties as assigned

Requirements:

• BS in Chemistry or other Physical Science
• 2-5 years of testing experience in FDA regulated pharmaceuticals or medical device industries
• Demonstrated experience with GMP/ISO regulations
• Proficient in HPLC, GC analyses, and prior experience in method development and method validation
• Demonstrated experience with basic lab instrumentation including UV/vis and FTIR spectrophotometers, pH Meters, and Osmometers
• Skilled in various wet chemistry techniques such as titrations and compendial ID testing
• Constantly strives to exceed goals, requirements, accomplishments, and expectations
• Ability to work flexible hours to complete work activities