Quality Operations Lead — GMP & Process Excellence

Best Formulations; California (MO); On-site; USD 110,000 - 125,000; Full time

Job summary

Sirio Nutrition California is seeking a QA/Quality Operations supervisor to oversee manufacturing quality, ensure compliance with GMP, CFR and FDA regulations, and manage batch records and deviations. The role requires a Bachelor’s degree and 5+ years in a quality-focused manufacturing environment.

You will lead cross-functional teams, mentor staff, review production records, support audits, and drive continuous improvement while maintaining strict adherence to company procedures and safety

Qualifications

• BA/BS in Science or related field with 5+ years in quality management in manufacturing.
• Knowledge of GMP, CFR and regulatory compliance requirements.
• Experience with FDA and cGMP in a production environment.
• Ability to lead investigations, root cause analysis and CAPA.
• Strong documentation and batch record review skills.

Responsibilities

• Monitor manufacturing activities for compliance with procedures and quality standards.
• Supervise, train, coach Quality Operations staff and assign daily tasks.
• Coordinate with cross-functional teams to investigate defects and drive improvements.
• Review and approve batch records and related quality documents.
• Support disposition decisions through test results and investigations.
• Lead investigations of deviations and customer complaints with corrective actions.
• Monitor quality metrics and communicate issues to management.
• Coordinate disposition of raw, in-process and finished materials with QC.
• Provide GMP training and participate in audits and regulatory inspections.

Skills

GMP knowledge

FDA & cGMP

Quality management

Regulatory compliance

Strong communication

Problem solving

Leadership

Education

BA/BS in Science or related field

Tools

Microsoft Office

Job description

Sirio Nutrition California is seeking a QA/Quality Operations supervisor to oversee manufacturing quality, ensure compliance with GMP, CFR and FDA regulations, and manage batch records and deviations. The role requires a Bachelor’s degree and 5+ years in a quality-focused manufacturing environment.

You will lead cross-functional teams, mentor staff, review production records, support audits, and drive continuous improvement while maintaining strict adherence to company procedures and safety