Quality Control Manager (Production Operations)

Purpose

The Quality Control Manager is responsible for managing execution of quality control activities to support production, which includes equipment maintenance/calibration, equipment qualifications, environmental monitoring, and deviation/nonconformance investigations.

Duties & Responsibilities

• Manage and oversee technical review of HCT/P production records in accordance with standard operating procedures and regulatory requirements
• Support scheduling and execution of cleanroom/equipment cleaning, decontamination, maintenance, calibration, and environmental monitoring
• Support environmental trending data analysis
• Support development and execution of equipment qualification protocols and summary reports in accordance with regulatory requirements and industry best practices
• Identify and resolve equipment qualification issues and exceptions/deviations
• Review and approve equipment qualification protocols, execution data, and summary reports to ensure accuracy, completeness, and compliance with established standards
• Initiate change orders to document change requests and associated risk assessments
• Initiate and conduct investigations for deviations, nonconformances, and CAPAs
• Lead re-training driven by quality event corrective actions
• Author/revise procedures according to FDA, AATB, and other applicable regulations
• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, and industry standards
• File and maintain records in accordance with standard operating procedures
• Manage direct reports
• 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
• Attend/participate in offsite business meetings/conferences
• Report to work in-person and start job duties on time
• Complete required hours on assigned work shifts to complete assigned responsibilities and duties properly
• Attend all scheduled meetings and appointments
• Perform other related duties as assigned

Skills & Abilities

• Leadership & Management
• Attention to Detail
• Organized
• Verbal/Written Communication
• Analytical Thinking
• Technical Writing
• Multi-tasking
   

Education & Experience

• Bachelor’s degree in a biological science or related field
• At least 5 years of experience in quality in an FDA regulated environment for HCT/Ps and/or medical devices (or related field), with progressive management responsibility/experience
• Experience with audits to include FDA, ISO and internal audits preferred
• Valid Class “C” drivers license