Quality Control Analyst II

Strategic Focus Areas:

  1. Perform all activities within the confines of the Quality System and cGMP principles
  2. Participate in projects and activities which support the growth efforts of the Company
  3. Maintain cost discipline within assigned programs

Specific Tactical Responsibilities:

  1. Testing of incoming raw material according to USP, EP, or ACS Reagent Index
  2. Performance of QC analytical chemistry assays, HPLC, GC, Headspace, Moisture analyzer, Karl Fisher as well as we chemistry assays.
  3. Testing of in process and release manufacturing samples, stability samples and Engineering/R&D samples using the following instrumentation/techniques:
    • 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
  1. Complete required documentation for all work activities according to Good Documentation Practices; reviews lab notebooks and verifies results of other Analysts
  2. Collaborates with R&D to develop test methods for new products
  3. Performance of QC method qualification, validation and transfers
  4. Researches and optimizes Test methods according to accepted industry best practice; performs qualification and validation of methods
  5. Report procedural deviations and nonconformances to management; preforms investigations as assigned and follows through to closure of corrective action
  6. Maintain current training on all assigned procedures to include read & understood, skills development and classroom training activities as required
  7. Performance of QC general laboratory equipment maintenance
  8. Participate in other projects as assigned

Required Qualifications:

    1. Requires BS in Chemistry or other Physical Science or 7-10 years of relevant experience.
    2. 5+ years testing experience in FDA regulated pharmaceuticals or medical device industries
    3. Demonstrated experience with GMP/ ISO regulations
    4. Proficient in HPLC, GC analyses and prior experience in method development and method validation.
    5. Demonstrated experience with basic lab instrumentation including UV/vis and FTIR spectrophotometers, pH Meters, and Osmometers
    6. Skilled in various wet chemistry techniques such as titrations and compendial ID testing
    7. Constantly strives to exceed goals, requirements, accomplishments and expectations
    8. Ability to work flexible hours to complete work activities


Desired Experience, Knowledge, and Skills:

  1. Experience with Viscometers, TOC Analyzers, or Conductivity Meters
  2. Experience in a results driven, team environment
  3. Ability to handle multiple priorities and meet established deadlines
  4. Experience maintaining spreadsheets and preparing simple graphing is preferred

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