Quality Control and Continuous Improvement Specialist I

Key Responsibilities

• Perform scientific analyses of raw materials, in-process materials, and finished products to ensure compliance with established quality standards.
• Select and test products according to defined QC protocols and specifications.
• Document, interpret, and analyze QC data to identify trends, deviations, and opportunities for process improvement.
• Take proactive ownership of problem identification, resolution, and risk mitigation.
• Conduct root cause investigations and assist in designing and implementing corrective and preventive actions (CAPAs).
• Use Lean, 5S, Six Sigma, process mapping, and other continuous improvement tools to optimize workflows, prevent defects, and improve efficiency.
• Develop and implement novel systems or tools to enhance quality and process reliability.
• Work collaboratively with QA, Operations, Veterinarians, Facilities & Maintenance, and other stakeholders to troubleshoot and resolve production or process issues.
• Support other operational functions as trained and qualified.
• Maintain accurate QC records, SOPs, work instructions, quality records, and other documentation in alignment with regulatory and internal standards.
• Ensure data integrity, audit readiness, and adherence to AAALAC, IACUC, USDA, CDC, and other relevant regulatory requirements.
• Provide on-site support for internal, customer, and regulatory audits.
• Participate in continuous improvement initiatives, including 5S activities, FMEAs, Gemba walks, and other operational excellence programs.
• Help drive a culture of continuous improvement and operational excellence by leading by example.
• Provide guidance, mentoring, and training to junior QC staff, supporting their professional development.
• Perform additional duties as assigned to support QC and CI objectives.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field.
• Knowledge of NC/RCI/CAPA processes, audits, and regulatory compliance.
• Experience with Lean, Six Sigma, 5S, FMEA, process mapping, and statistical data analysis preferred.
• Strong analytical, problem-solving, and communication skills.
• Ability to work collaboratively in a fast-paced, cross-functional environment.