Quality Specialist

Overview

What This Job Involves This position provides comprehensive quality assurance support for pharmaceutical facility operations, ensuring all maintenance, warehouse and operations activities comply with company policies, client procedures, and FDA cGMP regulations. The Quality Specialist maintains the highest quality standards in regulated manufacturing environments while supporting continuous improvement initiatives and working closely with facility management teams and client quality control personnel.

Your day-to-day tasks will include:

• Executing Quality Compliance programs for cGMP manufacturing facilities and ensuring full regulatory adherence
• Conducting facility self-assessments and vendor/supplier audits to maintain quality standards
• Preparing and revising SOPs, change control documentation, investigations, and CAPAs
• Developing training materials for facilities maintenance and operations teams; and maintaining personnel qualification files
• Tracking and following up on quality events with department managers to ensure resolution
• Supporting achievement of Key Performance Indicators outlined in Service Level Agreements
• Interfacing with client quality control personnel to ensure proper documentation and SOP adherence
• Development and execution of Quality Controls for warehousing and operations
• Train, mentor and develop JLL personnel in areas of GMP, GDP, Compliance and Regulations

• Bachelor's degree in Engineering or equivalent experience in related field
• Minimum 5 years of experience in pharmaceutical, biotech, medical device or life sciences sectors under GMP regulations
• Minimum 4 years of regulatory quality and statutory compliance experience
• Quality Assurance role experience in FDA-regulated manufacturing facilities
• Strong knowledge of cGMP regulations as applied to maintenance and manufacturing equipment
• Proficiency with Quality Engineering techniques, CMMS systems, and Quality Management Systems
• Advanced computer skills including Microsoft Word, Excel, and Power Point
• Excellent verbal and written communication skills
• Navigates complex operational challenges by diagnosing issues, evaluating options, and driving timely, effective resolutions
• Proficient in SAP or similar ERP systems, document management/control systems, and digital maintenance tools used in regulated environments

• Auditing experience in pharmaceutical or regulated manufacturing environments
• Experience with documentation control systems and change management processes
• Background in facility maintenance operations within pharmaceutical settings
• Knowledge of Quality Management Systems implementation and continuous improvement methodologies
• Experience developing training programs for technical teams
• Familiarity with client satisfaction survey processes and KPI management
• Self-motivated and detail-oriented work style with ability to function independently in dynamic team environments
• Professional certifications in Quality, Regulatory Affairs, or cGMP (e.g., ASQ, RAC, or equivalent)