Summary

Provide leadership and oversight for Training and Procedural Document Programs which are critical activities for Sharp Clinical Services (SCS) to ensure the quality of the manufactured product. Support the organization through the administration, use and maintenance of electronic Quality Management System, QualityOne, within SCS. Employ industry  best practices and management solutions to ensure compliance for documented required procedures.

Essential Duties and Responsibilities

• Support quality management systems operation in a day-to-day aspect within the organization, assisting with implemented modules within QualityOne to ensure compliance.

• Business Administration and User Access management (creation, modification and removal of user accounts and security permissions) for QualityOne. Providing subject matter expertise to assure Quality System records meet global regulatory requirements and industry practices.
• Supporting the management and tracking of quality system records (i.e. NCRs, CAPAs, Effectiveness Checks and Change Controls) for adherence to organizational or departmental targets.
• Driving improvements and supporting changing regulations/requirements of quality system content and processes.
• Supporting generation of quality system metrics and trending, and escalate issues as required.
• Supporting training, usage, and ongoing configuration changes to the electronic QMS system and collection of metadata needed for existing documents in the Quality System, Veeva.
• Compiling analysis for and communicating upcoming/aging Quality System records to Record Owners.
• Participating in Inspection Readiness activities.

• Ensure that all proposed changes are reviewed by qualified personnel to assess any impact on other processes or documents and all are in compliance with cGMP, government regulations and quality standards.
• Represent the Company during regulatory inspections (e.g. FDA, DEA) and audits by partner companies and internal system audits and minute taking to ensure that our training function and records and our procedural documents are represented fairly, accurately and are current and available for review.
• Establish and manage the records and retention activities for the Quality Units.
• Participate on cross-functional teams and projects representing quality in positive and compliant manner
• Adhere to set safety standards.
• Achieve expected performance measures.

Additional duties as assigned.