QC Analyst II

Role Summary

The Quality Control Analyst II 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. The position follows established procedures in the execution of daily activities and completes required documentation.

Responsibilities

• Testing of incoming raw material according to USP, EP, or ACS Reagent Index
• Performance of QC analytical chemistry assays, HPLC, GC and GC/MS, Headspace, Moisture analyzer, Karl Fischer as well as wet chemistry assays
• Testing of 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; reviews lab notebooks and verifies results of other Analysts
• Collaborates with R&D to develop test methods for new products; Performance of QC method qualification, validation and transfers
• Researches and optimizes test methods according to accepted industry best practice; performs qualification and validation of methods
• Report procedural deviations and nonconformances to management; performs investigations as assigned and follows through to closure of corrective action
• Maintain current training on all assigned procedures to include read & understood, skills development and classroom training activities as required
• Performance of QC general laboratory equipment maintenance
• Participate in other projects as assigned

Qualifications

• Required: Requires BS in Chemistry or other Physical Science or equivalent experience
• Required: 2 – 5 years testing experience in FDA regulated pharmaceuticals or medical device industries
• Required: Demonstrated experience with GMP/ ISO regulations
• Required: Proficient in HPLC, GC analyses and prior experience in method development and method validation
• Required: Demonstrated experience with basic lab instrumentation including UV/vis and FTIR spectrophotometers, pH Meters, and Osmometers
• Required: Skilled in various wet chemistry techniques such as titrations and compendial ID testing
• Required: Constantly strives to exceed goals, requirements, accomplishments and expectations
• Required: Ability to work flexible hours to complete work activities
• Preferred: Experience with Viscometers, HPLC, GC, GC/MS, TOC Analyzers, or Conductivity Meters
• Preferred: Experience in a results driven, team environment
• Preferred: Ability to handle multiple priorities and meet established deadlines
• Preferred: Experience maintaining spreadsheets and preparing simple graphing is preferred

Skills

• Viscometers, HPLC, GC, GC/MS, TOC Analyzers, or Conductivity Meters
• Experience in a results driven, team environment
• Ability to handle multiple priorities and meet established deadlines
• Experience maintaining spreadsheets and preparing simple graphing is preferred

Education

• BS in Chemistry or other Physical Science or equivalent experience