Job Description

Essential Functions:

• Lead quality problem-solving and root cause analysis to prevent issues in manufacturing.
• Investigate technical issues, testing status, and implement CAPA procedures for product quality and regulatory compliance.
• Conduct supplier audits and inspections to verify system and product quality.
• Represent the quality team in key meetings and work independently to resolve major issues.
• Coordinate teams to address Out of Specifications, Deviations, CAPAs, and Change Controls.
• Identify and resolve quality problems in production, QC, and analytical testing, evaluating the effectiveness of corrective actions.
• Develop key quality metrics and analyze quality data for continuous improvement.
• Update SOPs, conduct audits, and promote quality awareness across the organization.
• Ensure compliance with company policies, cGMP, safety, and environmental regulations.
• Participate in required safety and GMP training.

Competencies:

• Strong knowledge of quality assurance methods and manufacturing processes.
• Experience with quality management software (CAPA, FMEA, SPC).
• Excellent analytical, critical thinking, and problem-solving skills.

Required Education & Experience:

• Bachelor's degree in Engineering (Master's preferred).
• 3+ years of experience in pharmaceuticals
• Strong knowledge of quality systems (ISO 9001, GMP, FDA regulations) and industry standards.
• ASQ Certified Quality Engineer (CQE) certification is a plus.

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