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). The Quality Systems Specialist will partner with IT to create and maintain QMS processes to meet the needs of QA departments and manage effectiveness and standardization of the QMS across the organization. This includes the capability to document best practices, identify process inefficiencies, and ensure alignment of QA processes with corporate strategy and policy.
The Quality Systems Specialist will be responsible for producing reporting, gathering metrics, and intaking business requirements for enhancements, add-ons, and executing on complex process-oriented projects.
Other responsibilities include troubleshooting problems as reported by users, supporting Web access to eQMS services and maintaining a secure systems environment. They will also facilitate infrastructure expansion in tandem with the eQMS vendor, based on application needs and anticipated growth andwork with project managers to coordinate and plan project tasks and resources.
PRIMARY DUTIES AND RESPONSIBILITIES:
· 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. May perform the roles of document Author, Reviewer, and/or Approver.
· 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.
· Works closely with IT / QA to manage risk, verification, quality, and validation plans.
What your background should look like
· Bachelors degree or technical institute degree/certificate or equivalent work experience.
· Typically requires a minimum of three (3) years of relevant experience deploying and/or administrating Quality Management solutions
· Relevant certification is preferred
· Requires strong knowledge and experience with multiple infrastructure solutions.
MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
· Ability to work cross functionally to develop and maintain QMS system, documentation, and regulatory requirements
· Proficiency in the use of computerized systems to effectively administer the specialized electronic quality management system (eQMS) applications, as well as efficiently utilize common office applications (e.g., Outlook, PowerPoint, Word, Excel, Visio and Adobe Acrobat).
· Strong organization skills
· Good analytical and problem solving skills.
· Ability to communicate effectively both orally and in writing
· Good interpersonal skills; solid team player
· Exceptional customer service skills
· Good group presentation skills
· Ability to lead tech