Supplier Quality Specialist in Allentown

Senior Quality Assurance Compliance Specialist

Provides continuous oversight of all daily Quality activities to assure compliance with internal procedures and regulatory requirements. Provides 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 training
• Provides support to QA management during regulatory audit
• Reviews BOMs, inspection plans, pallet patterns, calibration records and SOP
• Performs internal audits and assists in writing reports for audit
• Maintains and revises procedures related to the quality assurance activities
• Supports Annual Product Review (APR) reports by collecting batch record data, creating and maintaining database
• Maintains the vendor complaint process
• Maintains, monitors, and provides trend analysis of DIs, LIs, CAPAs, customer complaints, and change control
• 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 Request
• 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 logbook
• 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 audit
• 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 skill
• 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 regulation
• Strong verbal and written communication skills with the ability to interact across functions, departments, and seniority level
• Expert level user for Quality computer system
• 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 requirement