Quality Manager

Jobtailor; Sumter (SC); On-site; USD 65,000 - 85,000; Full time

Job summary

Jobtailor in Sumter, SC is seeking a Quality Management professional to evaluate processes, implement corrective actions, and oversee the plasma donor center's quality-management system.

You will drive continuous quality improvement, ensure adherence to FDA and CGMP requirements, and manage audits, training, and documentation to protect donor safety and product quality.

Qualifications

• Bachelor of Science degree or equivalent.
• Typically requires 2 years of related experience in a medical and/or cGMP regulated environment.
• Experience with plasma or whole blood preferred.
• Ability to understand and assess FDA regulations.
• Proficiency in root cause analysis and corrective/preventive actions.
• High level of proficiency with computers.
• Full command of mathematics.
• Ability to travel when needed for meetings, events, and occasional support of other centers.
• Ability to work in office and/or laboratory/manufacturing environments.
• Ability to use required personal protective equipment.

Responsibilities

• Evaluate processes, develop action plans, and coordinate strategic implementation of quality-system processes and corrective actions at the plasma donor center.
• Maintain oversight of the center's quality management system and drive continuous quality improvement.
• Ensure compliance with applicable state, federal, and company-designated regulations.
• Implement SOPs for quality control and regulatory compliance.
• Oversee the center training program, audit training records, and maintain training files.
• Collaborate with the Center Manager to maintain product quality, donor suitability, and donor safety.
• Direct and manage Quality Systems Associate personnel functions.
• Oversee internal and external audits, including preparation, execution, responses, corrective/preventive actions, and follow-up.
• Assess and improve quality and training systems through trend recognition, failure investigation, and direct observations.
• Document deviations and customer complaints and perform root-cause analysis.
• Investigate trends and follow up on corrective/preventive actions and process-improvement plans.
• Oversee product and biohazard waste shipments, including regulatory compliance, labeling, documentation, and final authorization.
• Review unsuitable test results, unit lookback information, donor adverse-event reports, and related documentation.
• Ensure annual job and center training is completed and documented.
• Perform employee training observations before independent work release.
• Verify supplies and materials meet quality requirements and are properly stored; investigate nonconformance and initiate rejection.
• Determine donor suitability and manage donor deferrals and reinstatement activities.
• Prepare quality-analysis reports and research systemic compliance issues.
• Ensure CLIA proficiency-test surveys, complaint investigations, and training are documented.
• Hold monthly Quality Meetings and manage action outcomes

Skills

Quality management systems

Regulatory compliance

Root cause analysis

Training oversight

SOP implementation

Education

Bachelor of Science

Job description

Evaluate processes, develop action plans, and coordinate strategic implementation of quality-system processes and corrective actions at the plasma donor center
Maintain oversight of the center's quality management system and drive continuous quality improvement
Ensure compliance with applicable state, federal, and company-designated regulations
Implement SOPs for quality control and regulatory compliance
Oversee the center training program, audit training records, and maintain training files
Collaborate with the Center Manager to maintain product quality, donor suitability, and donor safety
Direct and manage Quality Systems Associate personnel functions
Oversee internal and external audits, including preparation, execution, responses, corrective/preventive actions, and follow-up
Assess and improve quality and training systems through trend recognition, failure investigation, and direct observations
Document deviations and customer complaints and perform root-cause analysis
Investigate trends and follow up on corrective/preventive actions and process-improvement plans
Oversee product and biohazard waste shipments, including regulatory compliance, labeling, documentation, and final authorization
Review unsuitable test results, unit lookback information, donor adverse-event reports, and related documentation
Ensure annual job and center training is completed and documented
Perform employee training observations before independent work release
Verify supplies and materials meet quality requirements and are properly stored; investigate nonconformance and initiate rejection
Determine donor suitability and manage donor deferrals and reinstatement activities
Prepare quality-analysis reports and research systemic compliance issues
Ensure CLIA proficiency-test surveys, complaint investigations, and training are documented
Hold monthly Quality Meetings and manage action outcomes

Requirements

• Bachelor of Science degree or equivalent
• Directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements
• Typically requires 2 years of related experience in a medical and/or cGMP regulated environment
• Experience with plasma or whole blood preferred
• Ability to understand and assess FDA regulations
• Proficiency in root cause analysis and corrective/preventive actions
• High level of proficiency with computers
• Full command of mathematics
• Ability to travel when needed for meetings, events, and occasional support of other centers
• Ability to work in office and/or laboratory/manufacturing environments
• Ability to use required personal protective equipment
• Ability to lift and carry objects up to 35 lbs
• Ability to communicate complex information and understand spoken information
• Ability to work independently with little guidance
• Ability to work with diverse groups to obtain consensus
• Ability to apply abstract principles to solve complex conceptual issues

Core Competencies

Demonstrates expertise in quality management systems, regulatory compliance, and continuous quality improvement within a plasma donor center environment. Proficient in root cause analysis, corrective actions, and training program oversight to ensure donor safety and product quality.

Highest-signal resume keywords

• Quality Management Systems
• Regulatory Compliance
• Root Cause Analysis
• CGMP Experience
• Training Program Oversight

ATS Optimization Keywords

Hard Skills

• Quality Control
• Corrective Actions
• Trend Analysis
• Data Documentation
• FDA Regulations
• Mathematics Proficiency
• SOP Implementation
• Audit Preparation
• Process Improvement
• Donor Suitability Assessment

Soft Skills

• Communication
• Independent Work
• Consensus Building
• Problem Solving
• Team Collaboration

Certifications & Qualifications

• Bachelor of Science Degree

Industry Keywords

• Plasma
• Whole Blood
• CGMP
• Quality Improvement
• Biohazard Waste Management
• CLIA Proficiency Testing
• Training Documentation
• Donor Adverse-Event Reports
• Internal Audits
• External Audits