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.