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Quality Audtior

Quality Audtior

Germer InternationalAllentown, PA, United States
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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 with a strong background in auditing and supplier onboarding to join their growing team.

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
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    Quality • Allentown, PA, United States

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