Job Description

Senior Quality Assurance Compliance Specialist

Our client, a global leader in the development and manufacturing of generic injectable and inhalation products, is looking for someone who has lead supplier audits that can join their growing team. The Senior Quality Assurance Compliance Specialist will independently travel to supplier sites to either requalify or qualify them. Additionally, this person will be involved in the supplier onboarding and quality agreements.

Job Overview

• Provides continuous oversight of all daily Quality activities to assure compliance with internal procedures and regulatory requirements.
• Provide proper control, review, and management of site documentation to ensure GMP and regulatory compliance.

Essential Duties and Responsibilities:

• Supports Annual Product Review (APR) reports by collecting batch record data, creating and maintaining databases
• Maintains the vendor complaint process
• Maintains, monitors, and provides trend analysis of DIs, LIs, CAPAs, customer complaints, and change controls
• Performs special projects and/or assignments as indicated by Quality Management
• Oversees and reviews Obsolete material destruction
• Performs Quality inspections on packaging line as needed
• Maintains supplier approval program
• Supports/Maintains site Document Control System:
• Reviews, approves, and closes out Document Change Requests
• Tracks changes using DCC spreadsheet and supports actions through closure
• Maintains original documentation archive and archives documents offsite
• Prints new and revised documents; issues forms and logbooks
• Reviews documentation submitted for routing in eDMS for proper formatting and accuracy
• Loads documents into an electronic Documentation Management System (eDMS)
• Routes documents for approval in the eDMS
• Recalls documentation for audits in a timely manner
• Performs external audits and assists in writing reports for audits
• Responsible for maintenance and revision of procedures related to document control
• May require up to 25% travel

Key Competencies:

• Critical Thinking — using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems
• Excellent customer service skills and professional demeanor to interface effectively with all internal and external customers
• Excellent verbal and written communication skills
• Energetic, enthusiastic, and motivated disposition
• Attention to detail with strong organizational skills
• Ability to explain problems, solutions, make recommendations, and manage various urgent requests professionally
• Ability to analyze data/trends to make sound regulatory interpretation while preparing metrics and reports
• Ability to drive projects related to implementation of new workflows and system updates

Education / Experience:

• Bachelor’s degree in relevant scientific quality assurance / technical field
• 5+ years of experience
• Strong understanding of pharmaceutical cGMP, industry standards, and regulations
• Strong verbal and written communication skills with the ability to interact across functions, departments, and seniority levels
• Expert level user for Quality computer systems
• Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems
• Thorough understanding of computer system validation and GAMP requirements

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