Quality Compliance Specialist - 12 Month FTC

• Responsible for the execution of a variety of compliance requirements within the Quality Management System (QMS) of the site
• Provide Reports to site in relation to Quality Management System (QMS) as required
• Provide regular reports on site's metrics to appropriate management
• Quality system integration
• Data Integrity system
• Applicable training requirements (i.e. GMP introductory and refresher training)
• Quality Risk Management
• Supplier management system
• Support the completion and execution of Site Quality Council and Annual Product Reports
• Communicate with cross functional departments sites' compliance and quality systems issues
• Supporting or Conducting audits of suppliers/outsourced providers, where applicable
• Supporting the coordination of self-inspection system in GWWO, where applicable
• Provide support ensuring external audit readiness and during external audits and corporate internal audits
• Ensures the corrections of findings, risks and recommendations are promptly and thoroughly incorporated into the quality systems
• Identifies and shares "Best Practices"
• Participate in investigations of quality system issues and drives CAPA implementation to ensure CAPA findings, risks, recommendations, and outcomes are appropriate and are clearly documented and communicated
• Trends, analyses, and reports on quality data to improve product and process Quality; develop recommendations based on data analyses
• Managing and coordinating Supplier qualification process, supplier complaints, and supplier agreements
• Other activities related to QMS

Requirements

• Bachelor's degree (B.A./B.S.) or equivalent
• Two to four years' experience in the pharmaceutical and/or biotechnology-based industry (as deemed necessary by hiring manager)
• Experience with assisting or managing QA audits and inspections
• Good working knowledge of pertinent regulations and site SOPs
• Competence in Microsoft packages specifically word, excel and PowerPoint
• Excellent technical writing and analytical skills
• Flexibility
• Results orientated
• Process improvement and procedure writing expertise
• Solid problem-solving skills
• Previous experience in auditing
• Previous experience in health authorities' audits

Core Competencies

Demonstrates expertise in Quality Management Systems (QMS) compliance, including Quality Risk Management and Supplier Management. Proficient in data analysis and reporting to enhance product and process quality while ensuring audit readiness and effective CAPA implementation.

Highest-signal resume keywords

• Quality Management System (QMS)
• Quality Risk Management
• Supplier Management
• Audit Coordination
• Data Analysis

ATS Optimization Keywords Hard Skills

• Quality System Integration
• Data Integrity System
• GMP Training
• Technical Writing
• Process Improvement
• Procedure Writing
• Quality Auditing
• Regulatory Compliance
• Analytical Skills
• Problem-Solving

Soft Skills

• Flexibility
• Results Oriented

Industry Keywords

• Pharmaceutical Industry
• Biotechnology Industry
• Health Authorities Audits
• Site SOPs
• Self-Inspection System

Tools & Technologies

• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint