Senior Quality Assurance Compliance Specialist

Job Description

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:

• Responsible for the review, approval, and disposition of finished product for the site and final CoA signature
• Facilitates client project management as required ensuring “quality on time and in full”
• Coordinates the investigation and closure of non-conformances ensuring appropriate corrective and preventive actions (CAPA) and change controls are initiated and deviations are closed
• Leads or participates in focused deviation cross-functional investigations, improvement projects
• Reviews and approves laboratory investigations in a timely manner and ensures appropriate root cause is identified
• Provides assistance to other QA associates and assists with department trainings
• Provides support to QA management during regulatory audits
• Reviews BOMs, inspection plans, pallet patterns, calibration records and SOPs
• Performs internal audits and assists in writing reports for audits
• Maintains and revises procedures related to the quality assurance activities
• 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