Senior Quality Assurance Compliance Specialist

Job Description

Business: Critical Care
Department: Quality Assurance
Location: Bethlehem, PA

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.

Key Stakeholders: Internal

Quality Assurance Team, Site Management, All Departments

Key Stakeholders: External

FDA or other health organizations

Reporting Structure

Directly reports to Quality Assurance Supervisor

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 assist 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 assist 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 data bases
• Maintain the vendor complaint process
• Maintain, monitor and provide trend analysis of DIs, LIs, CAPAs, customer complaints and change controls
• Performs special projects and/or assignments as indicated by Quality Management
• Oversee and review of Obsolete material destruction
• Perform Quality inspections on packaging line as needed
• Maintain supplier approval program
• Support/Maintain site Document Control System
  • Review, approve and close out Document Change Requests
  • Tracking of changes using DCC spreadsheet and supporting actions through closure
  • Maintain original documentation archive and Archival of documents offsite
  • Printing of new and revised documents, Issuance of forms, logbooks
  • Review documentation submitted for routing in eDMS for proper formatting and accuracy.
  • Load documents into an electronic Documentation Management System (eDMS)
  • Route documents for approval in the eDMS
  • Recall documentation for audits in a timely manner
• Performs external audits and assist in writing reports for audits
• Responsible for maintenance and revision procedures related to document control
• May require up to 25% travel.

Key Competencies (knowledge, skills, and abilities every person must possess to be successful)

• 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 at all times 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 and make recommendations, and the ability to manage various urgent requests in a professional manner
• Ability to analyze data/trends to make sound regulatory interpretation while preparing metrics and reports
• The ability to drive projects in relation to implementation of new workflows and updates to new systems

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