Lead QA Release Tech

Description Overview

The Lead QA Release Technician is responsible for reviewing batch records for accuracy and compliance with cGMP and applicable procedures to ensure that the product meets acceptable specifications. This includes auditing the batch record release process and leading continuous improvement initiatives across the Quality department.

Scope of the Role

• Review batch records for compliance with cGMP and internal procedures.
• Audit documentation and batch release processes to ensure regulatory compliance.
• Coordinate training efforts across shifts, harmonize training initiatives, and serve as the point of contact for QA learning plans.
• Identify and implement lean projects for technician roles, including SME identification and cross-functional participation.
• Lead cross-shift projects, team-building activities, and process consistency efforts.
• Manage release office workload requirements.
• Serve as a Subject Matter Expert SME during internal and external audits as needed.
• Must have the ability to communicate clearly and execute on business needs with multiple departments such as planning and customer service.
• Other requirements as needed as directed by QA leadership.

Experience Required

• High School Diploma or GED is required; Associate’s or Bachelor’s degree is preferred.
• Minimum of two (2) years of experience in an FDA-regulated industry. Six (6) years preferred for Lead-level responsibilities; fewer years may be considered with a degree.
• Excellent oral and written communication skills and strong interpersonal skills.
• Strong analytical skills, attention to detail, and ability to work independently and efficiently.
• Thorough understanding of cGMPs and ability to recognize variances.
• Preferred experience with:
• Manufacturing or packaging equipment and processes.
• Batch record review and documentation procedures.