Quality Lead I

Responsibilities

• Performs Quality Control Release Verifications (QCRVs) and processes Incident Reports (IRs) to support manufacturing operations while ensuring compliance with applicable procedures, quality standards, and Good Manufacturing Practices (GMP).
• Manages the QCRV and IR workflow to ensure laboratory testing requirements are identified, initiated, tracked, and completed before manufacturing rooms are released back to production.
• Reviews manufacturing documentation, laboratory testing requirements, and quality records to verify all required activities have been completed prior to authorizing room release.
• Interprets and executes quality procedures, work instructions, and manufacturing requirements while ensuring compliance with internal quality systems and regulatory expectations.
• Performs detailed research using available quality systems, documentation, historical records, and cross-functional resources to investigate issues, identify required actions, and support timely resolution.
• Applies advanced analytical and critical-thinking skills to evaluate complex manufacturing situations, identify potential quality risks, determine appropriate actions, and resolve issues that may impact manufacturing operations.
• Provides quality oversight of manufacturing processes to ensure compliance with established procedures, data integrity requirements, and quality system expectations.
• Collaborates with laboratory personnel, manufacturing associates, supervisors, managers, engineers, and other cross-functional departments to facilitate testing completion, issue resolution, and manufacturing continuity.
• Provides routine work direction, coaching, and training to Quality Operations Associates regarding quality systems, QCRV processing, -Incident Report management, and manufacturing support activities.
• Escalates quality concerns, testing delays, compliance risks, or manufacturing issues to Quality Management as appropriate.
• Supports quality investigations by gathering information, reviewing documentation, identifying potential root causes, and assisting with implementation of corrective actions.

Qualifications

• Bachelor’s degree in a science, engineering, or related technical field preferred.
• Six years of experience in Quality Assurance, Quality Operations, Manufacturing, Laboratory Operations, or a related GMP-regulated environment.
• Demonstrated experience managing Quality Control and Incident Reports, manufacturing documentation, and quality system workflows.
• Strong understanding of GMP regulations, documentation practices, manufacturing processes, laboratory testing requirements, and quality systems.
• Prioritizes interpretation of technical procedures, performance of investigations, conducting research, and communication across multiple functional areas.
• Ability to work non-standard schedules as business needs require.

Expertise

• Regular and predictable on-site attendance.

Benefits

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement.