Quality Assurance Inspector Lead* (On-Site)

Lief Labs is a premier formulation and product development innovator and manufacturer of dietary supplements. Our in-house Product Development and R&D team create the best-tasting and most cutting-edge formulations of supplements. Lief also houses a state-of-the-art, full-service Current Good Manufacturing Practice (cGMP) manufacturing facility, which offers custom solutions for a multitude of supplement categories. Lief collaborates with entrepreneurial firms to help them build premier brands. Our turnkey solutions allow us to engage in seamless partnerships that help brands with scalability and sustainable growth. Lief Labs is located in the Santa Clarita Valley (Valencia, CA.)

Summary

The Quality Assurance Inspector Lead is responsible for daily quality inspection activities within Lief operating under FDA 21 CFR Part 111 cGMP regulations. This role provides technical leadership to QA inspectors and ensures that in-process inspections, documentation reviews, and product release activities are conducted in compliance with internal procedures, regulatory requirements, and customer specifications.

The QA Inspector Lead supports batch record review, line clearance verification, label reconciliation, and manufacturing oversight to ensure product quality, regulatory compliance, and data integrity.

Responsibilities

Inspection and Testing:

• Lead and coordinate daily activities of QA Inspectors on the manufacturing floor.
• Perform routine inspections of raw materials, in-process products, and finished goods and execution of line clearances.
• Review and verify labeling, component usage, and reconciliation documentation. Conduct tests to verify product quality, using appropriate testing equipment and methods.
• Document and report inspection results, noting any deviations or non-conformances.
• Perform real-time oversight of manufacturing processes including blending, encapsulation, tableting, coating, packaging, and labeling.

• Ensure compliance with FDA 21 CFR Part 111 dietary supplement cGMP regulations.
• Review completed batch records for accuracy, completeness, and compliance with cGMP requirements.
• Maintain accurate and detailed records of inspections, tests, and findings.
• Assist in the preparation and review of quality documentation, including batch records and Certificates of Analysis (CoAs).

• Identify opportunities for process improvements and work with cross-functional teams to implement corrective actions.
• Participate in root cause analysis and CAPA (Corrective and Preventive Actions) processes to address quality issues.

• Provide training and guidance to production staff on quality standards and procedures.
• Assist in internal and external audits, providing necessary documentation and support.

• Deviations
• Nonconformance reports and Material Disposition
• Change control
• Investigation

• Adhere to all safety protocols and procedures to ensure a safe working environment.
• Contribute to environmental sustainability initiatives within the quality assurance processes.

• High school diploma or equivalent required; Associate's or Bachelor's degree in a scientific or technical field preferred.

• Strong attention to detail and excellent observational skills.
• Proficient in using laboratory and testing equipment.
• Good documentation and record-keeping skills.
• Ability to work independently and as part of a team.
• Strong problem-solving and analytical skills.
• Effective communication skills, both written and verbal.
• Bilingual in Spanish a plus