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QC Training Specialist

Job in Indianapolis, Marion County, Indiana, 46262, USA
Listing for: Harba Solutions Inc.
Full Time position
Listed on 2025-11-29
Job specializations:
  • Quality Assurance - QA/QC
  • Healthcare
    Data Scientist
Salary/Wage Range or Industry Benchmark: 60000 - 80000 USD Yearly USD 60000.00 80000.00 YEAR
Job Description & How to Apply Below

Job Responsibilities:

  • Develop, implement, and maintain training programs for Quality Control personnel, ensuring all team members are proficient in GMP procedures, laboratory techniques, and company quality systems.
  • Conduct classroom, on-the-job, and hands-on training for new hires, existing staff, and cross-functional employees on QC methodologies, equipment operation, and regulatory compliance.
  • Assess training needs through gap analysis, audits, and performance evaluations, and develop targeted training plans to address identified needs.
  • Maintain training records, documentation, and reports in compliance with GMP, GDP, and internal quality management requirements.
  • Collaborate with QC leadership, Quality Assurance, and Operations teams to ensure training programs support regulatory compliance, process improvements, and operational efficiency.
  • Evaluate the effectiveness of training programs through assessments, observations, and feedback, and update materials to reflect changes in regulations, SOPs, and company practices.
  • Provide guidance and mentorship to QC staff to reinforce adherence to quality standards and regulatory requirements.
  • Support cross-functional initiatives related to regulatory inspections, process validation, new product introductions, and continuous improvement projects.
Qualifications:
  • Bachelor’s degree in Life Sciences, Chemistry, Biology, or related field; advanced degree preferred.
  • 5+ years of experience in Quality Control within the biopharmaceutical or pharmaceutical industry.
  • Strong knowledge of GMP, GDP, and regulatory requirements for laboratory and manufacturing operations.
  • Experience developing and delivering training programs for technical personnel in a regulated environment.
  • Excellent communication, presentation, and interpersonal skills with the ability to engage learners and foster a culture of compliance.
  • Proficiency in training software, learning management systems (LMS), and documentation tools.
  • Hands‑on experience with QC analytical methods such as HPLC, LC‑MS, GC, dissolution testing, or spectroscopy.
  • Familiarity with process improvement methodologies such as Lean or Six Sigma.
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