Principal Quality Assurance Compliance

Job Description

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 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.