IT Administrator- Quality management System

Under direction of the QMS Lead Admin and Enterprise Quality Assurance Leadership, the Quality Management System Specialist will be responsible for the day to day support and development needs for AmerisourceBergens Quality Management System (QMS).

Requirements

• Manage the controlled documents (Policies, SOPs, WIs and Forms) in the eQMS and maintain them in compliance with corporate and/or regulatory requirements.
• Work with the rest of the QA management team in the development/revision and implementation of QA policies and procedures as required.
• Serve as the secondary (back-up) administrator of the eQMS for controlled documents, assignment of training, profile updates, vault creation, obsolescence of documents, etc.
• Support training for Quality Systems processes as needed.
• Assist the EQA team with performing internal audits, reviews of controlled documents, etc. as required.
• Provide support and consultation on the CAPA process, including the CAPA-intake processes and forms (such as deviations, non-conformances, complaints, audits, etc.).
• Follow-up and provide data required for key performance quality metrics related to controlled documents, CAPAs and continuous quality improvements.
• Recommend organizational process improvement initiatives based on identified trends and key performance quality metrics.
• Maintain status reports for quality systems activities and provide to stakeholders as scheduled/requested.
• Support the Business Process Owners (BPOs) in providing technical, procedural, and compliance-based guidance to eQMS users as needed.
• Provide support during regulatory inspections by Health Canada and during quality audits by customers and third party auditors.
• Provide assistance to the QA Managers and QA Director as required.
• Work under challenging deadlines and be accountable for completing work within specified time periods.

Benefits

• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Generous Parental Leave
• Tuition Reimbursement