Quality Control Supervisor

Purpose

The Quality Control Supervisor is responsible for overseeing quality control activities and ensuring that products or services meet both company and regulatory standards. The Quality Control Supervisor will oversee the team of Quality Control Specialists, develop and implement quality control policies and procedures, and coordinate with other departments to resolve quality control issues.

Responsibilities

• Oversee technical review of HCT/P production records and allografts in accordance with standard operating procedures and regulatory requirements
• Oversee review of quality control records to include equipment cleaning/maintenance, equipment qualifications, environmental monitoring, supply inspections, lot release testing
• Support scheduling and execution of cleanroom/equipment environmental monitoring
• Support data collection for metrics and Key Performance Indicators
• Initiate change orders to document change requests and associated risk assessments
• Initiate and support investigations for quality events
• Lead re-training driven by quality event corrective actions
• Author/revise procedures according to FDA, AATB, and other applicable regulations
• File and maintain records in accordance with standard operating procedures
• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures
• Supervise direct reports
• Provide constructive feedback and guidance to develop leadership in direct reports and department management
• Establish and monitor objective annual goals for direct reports
• Conduct performance reviews and establish performance improvement plans as needed
• Recruit, interview, and select personnel for hire
• Maintain acceptable attendance and punctuality for scheduled work hours and meetings. Ensure completion of assigned tasks and responsibilities within defined timeframes
• Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary
• Perform other duties as assigned

Skills

• Ability to work independently and in a team environment
• Excellent attention to detail and organization
• Excellent written and verbal communication
• Highest level of ethics and integrity
• Ability to lead and motivate the right behaviors
• Ability to multi-task and work in a fast-paced environment
• Strong technical writing
• Proficiency in Microsoft Office

Qualifications/Requirements

• Bachelor’s degree in a biological science or related field required
• At least 3 year(s) of experience in quality in an FDA regulated environment for HCT/Ps and/or medical devices, or related field required, with progressive management experience
• Supervisor experience preferred
• Clearance of favorable background investigation required.