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QC Training Specialist

Job Details

Company Headquarters - Lexington, KY
Full Time
4 Year Degree
QA - Quality Control




This individual is responsible for ensuring training is understood for all laboratory personnel and independently performing routine tasks in the QCC laboratory with minimal supervision.


Essential Duties:


  • Work in a safe manner in accordance with site procedures
  • Work with other departments to ensure each group is aware of training requirements for laboratory personnel
  • Perform or assign training for QCC personnel
  • Evaluate updates to QC laboratory training modules to determine retraining level required
  • Supports the development and maintenance of the laboratory training process
  • Perform incoming raw material sampling and testing, component inspection, in-process analyses, finished product release testing and stability testing
  • Maintain the laboratory in accordance with SOPs
  • Calibrate, operate and maintain analytical instrumentation for product testing, including routine preventive maintenance and troubleshooting
  • Write, revise and review Standard Operating Procedures, Material Specifications, Forms, Protocols and Reports
  • Understand analytical techniques and execute tasks below with minimal supervision or under the direction of a test method, standard operating procedure, or a protocol.
    • HPLC
    • UV/Vis
    • FTIR
    • GC
    • Nasal Spray testing
  • Participate in method transfers
  • Troubleshoot analytical procedures and recommend changes and improvements in methodology
  • Prepare and present data summaries as needed
  • Recommend and implement, as required, innovative approaches to problem solving
  • Manage time effectively
  • Mentor Chemist I and II
  • Other duties as assigned

Knowledge, skills and abilities:

  • Outstanding capabilities for multitasking and adjusting priorities in response to changing conditions and schedules
  • Team player with well-developed interpersonal, organizational, and communication skills
  • Ability to handle stressful situations
  • Good method validation knowledge
  • Good instrument qualification knowledge
  • Understand cGMPs
  • Good investigative skills for OOS, OOT and aberrant result laboratory investigations
  • Excellent oral and written communication skills
  • Advanced knowledge in data acquisition systems such as Empower CDS


  • Bachelor’s in Chemistry or related field with at least 6 years pharmaceutical industry experience
  • Qualified to work with controlled substances