Quality Systems Coordinator
Job Description

Are you looking to make a difference in a patient’s life?  At Innomar Strategies, a company of AmerisourceBergen, you will find an innovative culture that is patient focused and dedicated to making a difference.  As an organization, we are united in our responsibility to create healthier futures.


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

  • 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:

  • 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


We offer competitive total rewards compensation. Our commitment to our associates includes offering benefit programs that are comprehensive, competitive and will meet the needs of our associates.

  • Competitive compensation packages
  • Comprehensive health and dental plans
  • Flexible & remote working options
  • Employer RRSP-matching
  • Online peer-to-peer recognition program
  • Corporate discounts with multiple establishments, including fitness centers
  • Health & Wellness program with onsite yoga and massage therapy



AmerisourceBergen is a publicly traded Fortune 11 global healthcare solutions company and is one of the world's largest pharmaceutical services companies. Innomar Strategies, a part of AmerisourceBergen, is Canada’s leading patient support provider for specialty pharmaceuticals. Through our Integrated Service Model, we deliver customized solutions to improve product access, increase supply chain efficiency, and enhance patient care. Innomar is the trusted expert in specialty pharmaceuticals with an unwavering commitment to patients.





Job Requirements

 

Company Overview

Innomar Strategies was founded in 2001 around the kitchen table of our current president, Guy Payette, and his partners. The company originally specialized in market access and reimbursement consulting, and gradually expanded its capabilities to include fully integrated patient support programming, nursing support, and specialty logistics. By the end of 2008, the company had grown to have over 450 associates.

In 2009, AmerisourceBergen acquired Innomar Strategies further establishing the company’s expertise in specialty pharmaceuticals. As part of AmerisourceBergen, Innomar Strategies is connected with a global leader in healthcare with over $135 billion of annualized revenue and 18,000 associates. AmerisourceBergen has an established history of delivering innovative programs and solutions across the pharmaceutical supply channel.

With over 1,200 associates and a nationwide footprint, Innomar Strategies is Canada’s leading service provider to specialty pharmaceutical and biotech manufacturers. Innomar is differentiated by their Integrated Service Model, which provides customized solutions to improve product access, increase supply chain efficiency, and enhance patient care. Manufacturers trust Innomar Strategies to deliver innovative brand solutions throughout the product lifecycle.


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