Senior Quality Assurance Compliance Specialist

Job Description

Provides continuous oversight of daily Quality activities to ensure compliance with internal procedures and regulatory requirements. Responsible for documentation control, review, and management to maintain GMP and regulatory compliance.

• Review, approve, and disposition finished products and provide final Certificate of Analysis (CoA) approval
• Facilitate client project management to ensure quality deliverables are completed on time and in full
• Cook up investigation and closure of non-conformances, ensuring CAPA and change controls are initiated and completed
• Lead or participate in cross-functional deviation investigations and improvement projects
• Review and approve laboratory investigations, ensuring root cause identification
• Support QA team members and assist in departmental training
• Provide support during regulatory audits
• Review BOMs, inspection plans, pallet patterns, calibration records, and SOPs
• Perform internal audits and assist in audit report preparation
• Maintain and revise QA procedures
• Manage vendor complaint processes
• Monitor and trend deviations, laboratory investigations (LIs), CAPAs, customer complaints, and change controls
• Perform special projects as assigned by Quality Management
• Oversee and review obsolete material destruction processes
• Conduct quality inspections on packaging lines as required
• Maintain supplier approval programs
• Support and maintain site Document Control System
• Review, approve, and close Document Change Requests
• Track document changes using DCC tools and ensure closure of associated actions
• Maintain document archives, including offsite storage
• Print and issue controlled documents, forms, and logbooks
• Routinely route documents for approval within eDMS workflows
• Retrieve documentation for audits in a timely manner
• Maintain and revise document control procedures

Key Competencies

• Strong critical thinking and problem-solving skills
• Excellent customer service and professional communication skills
• Strong verbal and written communication abilities
• Energetic, motivated, and detail-oriented approach
• Strong organizational skills with attention to detail
• Ability to analyze data, identify trends, and make regulatory decisions
• Ability to explain issues, propose solutions, and manage urgent requests effectively
• Capability to drive projects and implement process/system improvements

Education/Experience

• Bachelor’s degree in a scientific, quality assurance, or technical field
• Minimum 5+ years of relevant experience