Quality Assurance Supervisor

Purpose 

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

Responsibilities

• Assign tasks and responsibilities to QA Specialists to ensure adequate coverage and efficiency
• Oversee daily/weekly/monthly QA specialists assigned tasks
• Provide training and mentorship to new department employees on quality processes and procedures
• Support data collection for metrics and Key Performance Indicators
• Identify, initiate, and support the investigation of quality events
• Author/revise standard operating procedures in accordance with relevant regulations/standards, and internal organizational policies and standard operating procedures
• Support development of equipment, process, and software qualification, verification, and/or validation plans
• Review equipment, process, and software qualification, verification and/or validation execution data
• Support and/or perform internal and external audits
• Supervise the review of HCT/P donor records for final product release in accordance with standard operating procedures and regulatory/accrediting agency requirements
• Supervise the review of quality control records to include equipment cleaning/maintenance, environmental monitoring, and supply inspections
• Supervise the inspection of HCT/P products in accordance with standard operating procedures and regulatory requirements
• 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
• Manage 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
• Effective project management
• Proficiency in Microsoft Office

Qualifications/Requirements

• Bachelor’s degree in biological science, engineering, or related field, from an accredited college or university required
• At least 2 years of experience in an FDA regulated environment for HCT/Ps, medical devices, pharmaceuticals, and/or related field required
• Supervisor experience preferred
• Clearance of favorable background investigation required