General Summary

The Quality Assurance Inspector Lead is responsible for the assessment of quality practices in the manufacturing and compounding areas. Assist Quality Engineers / Quality Operations specialists with various Quality tasks. This role will utilize process improvement tools to gain an understanding of process performance and suggest improvement opportunities to Quality Management. This position will train and mentor production employees on current good manufacturing practices and good documentation practices.

Key Accountabilities

• Participates in the nonconformance process to ensure timely completion of documentation stages.
• Identifies, reports, and monitors Nonconforming events for the areas of responsibility.
• Supports product or process failure investigations and implements corrective and preventive actions to prevent reoccurrence.
• Interacts with cross-functional teams to resolve quality issues.
• Quality control and quarantine of all suspect or non-conforming products.
• Supports the Corrective and Preventive Action (CAPA) System for Quality Operations-related activities (effectiveness checks).
• Ensures quality system compliance for areas of responsibility.
• Responsible for monitoring cGMP’s.
• Performs Production Line and Compounding audits per customer and internal specification.
• Assist Operations in the interpretation of customer requirements.
• Identifies defects during production and notifies the Supervisor of any deviations from specification. Assists in determining corrective action.
• Verify labels/UPC/codes for production runs.
• Review and audit batch packet documentation generated by manufacturing for accuracy and completeness.
• Draft and at times perform AQL inspection sampling.
• Monitor production schedule for non-standard sample/hold requests.
• Hold and release products from hold when required.
• Review and reconciliation of plant logbooks for GMP / GDP practices.
• Assists in keeping the plant “Audit Ready”.
• Determines exit pressures as applicable.
• Promote teamwork and cooperation with line personnel and between departments by working closely together and helping in other areas if required.
• Observe and enforce safety / Quality Compliance rules.
• Performs other tasks or special projects as required or directed by Quality Engineer and/or Manager.

Requirements

• High School Diploma or GED.

• 2 years relevant Quality / Manufacturing experience.

• Ability to read, understand, and maintain records as required.

• Ability to handle multiple priorities in a fast-paced environment.

• Ability to work with minimal supervision.

• Strong Team Player.

• Ability to lift up to 35 lbs.

• Excellent attention to detail.

• Overtime and periodic weekend coverage required.

Cosmetics/personal care/OTC or other FDA-regulated manufacturing experience preferred.