Quality Systems Coordinator in Oakville at Innomar Strategies

Date Posted: 7/15/2020

Job Snapshot

Job Description

Under the general direction of the QA Manager and/or the QA Director, the Quality Systems Coordinator is primarily accountable for the administration of the electronic quality management system (eQMS) to support the continued development, improvement and implementation of Innomar’s Quality Systems. This is an individual contributor position responsible for maintaining, monitoring the effectiveness of, and providing improvements for, various Quality System program activities including control of documents (e.g., SOPs), tracking & trending deviations & audit findings, facilitation of CAPAs, and creation of Quality System trend reports for Management Review.
PRIMARY DUTIES AND RESPONSIBILITIES:
  • Serve as the primary administrator of the electronic quality management system (eQMS).
  • Manage user profiles and role assignments.
  • Create and maintain folder/vaults for controlled documents and quality event processes and forms.
  • Coordinate with the various management teams and the training department in the creation of training infocards, courses, roles, etc. in the eQMS.
  • Assist with and/or lead corporate quality systems training.
  • Provide support and consultation on the creation, periodic review, revision and obsolescence of controlled documents.
  • Provide support and consultation on the CAPA process, including the CAPA-intake processes and forms (such as deviations, non-conformances, complaints, audits, etc.).
  • Utilize structured, disciplined, and data-oriented problem-solving techniques for quality issues including but not limited to: identifying quality issues, performing formal investigations, conducting root cause analyses, writing and/or consulting on corrective action and preventive action plans.
  • Follow-up and provide data required for key performance quality metrics related to controlled documents, CAPAs(including feeder/intake processes & forms) and continuous quality improvements.
  • Perform analysis and report on trend data. Report and escalate system and process performance metrics to the Business Process Owners (BPOs).
  • 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 BPOs in providing technical, procedural, and compliance based guidance to eQMS users as needed.
  • Support training for Quality Systems processes 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.
  • Performs other projects as assigned

Job Requirements

  • Bachelor's degree, minimum (preferably in scientific discipline).
  • Experience with Quality Systems required.
  • Minimum of 2 years’ experience in a quality role preferred – specifically in SOP management, change controls, deviation investigations and CAPAs.
  • Applied knowledge of pharmaceutical Good Manufacturing Practices or device Quality System Regulations or ISO quality standards.
MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
  • Bilingual (English & French) an asset.
  • Working knowledge of Good Manufacturing Practices (GMP) or other Good Regulated Practices (GxP’s) as they relate to Innomar activities.
  • Exceptional quality of work and attention to detail.
  • Efficient in compiling, managing and interpreting data from various sources (e.g. from audits, complaints, non-conformances, etc.).
  • Advanced 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).
  • Effective organizational, time-management and prioritization skills.
  • Ability to work independently.
  • Demonstrated ability to meet tight deadlines in an environment of competing priorities.
  • Excellent interpersonal, written and verbal communication skills.
  • Refined strategic, collaboration and presentation skills.
  • Team player who respects all functional levels internally and externally.
  • Strong self-motivation and ability to work under limited supervision