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Quality Lab Associate II

Round Lake, Illinois | Sciences
Job ID: 89473
Listed on 4/11/2019

KellyMitchell matches the best IT and business talent with premier organizations nationwide. Our clients, ranging from Fortune 500 corporations to rapidly growing high-tech companies, are exceptionally served by our 1500+ IT and business consultants. Our industry is growing rapidly, and now is a great time to launch your career with the KellyMitchell team.

 

Job Title: Quality Lab Associate II

 

Job Description & Responsibilities

  • Conduct critical chemical, physical, and biological analyses on finished product stability samples. May also support testing of raw materials, initial, in-process and final product samples from the manufacturing facility, as required. Work under minimum supervision. 
  • Perform review of test data, which includes overall documentation practices. Perform review functions in LIMS or other computerized systems. 
  • Use sophisticated laboratory instrumentation and computer systems to collect and record data. May be required conduct validations. 
  • Perform advanced biological and chemical assays requiring precise analytical skills and understanding of chemistry principles. 
  • Complete all testing, including special project / protocol testing in a timely and appropriate manner to meet project schedules. 
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, cGxP, and QSR regulations. 
  • Investigate deviations and write exception documents. 
  • Participate in cross functional teams, which may impact production, increase efficiency, solve problems, generate cost savings and improve quality and provide new product support. 
  • Maintain laboratory safety requirements and perform laboratory audits as required. Audit SOPs and update, as required. 
  • Perform equipment maintenance and calibrations as required. Troubleshoot and resolve instrument problems. 

 

Skills, Experiences, Knowledge

  • Bachelor’s degree in Chemistry or biological science with analytical chemistry laboratory coursework and at least 2-5 years’ recent and relevant experience, or Master’s Degree in Chemistry, or Biological Sciences. 
  • A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials. 
  • Proficient in advanced wet chemistry, volumetric preparation techniques and instrumental methods of analysis 
  • Must demonstrate effectiveness in ability to train others, leadership, organization, teamwork/interpersonal skills, results orientation, and task completion. 
  • Must be able to handle multiple tasks concurrently and in a timely fashion.  
  • Must communicate effectively with managers, peers, and subordinates. 
  • Interpret available information and make recommendations to resolve technical challenges. 
  • Analytical chemistry instrumentation experience (e.g. HPLC, UPLC, UHPLC, GC, pH, KF, TOC, AA, GFAA, titrations, etc.) 
  • Pharmaceutical GMP/QC laboratory experience. 
  • Possess excellent quantitative analytical chemistry techniques. 
  • Normal visual acuity and ability to distinguish color are necessary. 
  • Must be able to lift and carry on average up to 15 pounds, stand for prolonged periods, and perform repetitive processes using both arms and hands. 
  • When working with pharmaceutical drugs, must enter health surveillance program and meet occupational health clearance to perform essential duties of the job. 
  • Ability to work in team oriented, dynamic fast-paced environment with competing priorities and due dates. 

 

Nice-to-have skills/experiences

  • Stability study execution experience is desired. 
  • Validation / Method Transfers experience is desired.