Job Description

The Quality Assurance Coordinator reporting to the Associate Manager, Quality Management System (QMS), will assist in the administration of quality systems & improvement initiatives as it relates to quality deviations, corrective and preventive actions, and document management.This position is permanent Full-Time and operates on remote basis and is open to candidates that reside in Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Nova Scotia, Ontario, Prince Edward Island, Quebec, Saskatchewan, Northwest Territories, Nunavut, and Yukon.DUTIES AND RESPONSIBILITIES

• Assists in the implementation of quality improvement initiatives across the Specialty Program Portfolio.
• In-accordance with GMP and GDP guidelines, assists in running document change control meetings and in effectively managing the review & approval process for documents, ensuring version control.
• Supports the administration and training initiatives on Quality Management Systems, including document and risk management processes.
• Supports Quality team in the management and maintenance of division wide Document Management System (DMS).
• Assists in creating and revising Specialty Program Portfolio standard policy documents and standard operating procedures.
• Maintains the Document Review Tracker and ensures departmental policy documents are up to date.
• Notifies Program teams of upcoming renewals and facilitate approvals.
• Manages document repository access rights.
• Supports and educates teams on conducting root cause analysis, investigations and writing effective CAPAs.
• Works closely with the Quality event (process deviation) owners to make sure Quality events are properly documented in the system, Root Cause Analysis (RCA) for nonconformances/deviations is conducted appropriately, and Corrective and Preventive Actions (CAPA) are simple, effective, and achievable.
• Classifies deviations (as Critical/Major/Minor) and conducts the effectiveness checks (if required).
• Monitors the CAPA plan timelines for completion, conducts follow-ups as needed, and closes QEs as per the due date.
• Supports the following audit/inspection document readiness-related activities:
• Maintains key audit/inspection readiness documents to ensure the most up-to-date version and correct documents are always available in the repository.
• Acts as a document runner during internal and external audits to retrieve audit related documents, as requested.
• Monitors Health Canada regulatory and quality requirements and proactively adapts the internal processes to meet the changing requirements.
• Performs other duties as assigned.

QualificationsWhat You Bring to the Team

• Professional degree and/or advanced background in Health discipline and/or Quality Certification.
• Minimum two to three (2-3) years of previous experience working with Quality initiatives in a healthcare setting.
• Experience working in Pharmaceutical GMP environment is an asset.
• Experience using Trackwise QMS system is an asset.
• Well versed with GxP documents.
• Effective business writing skills are required.
• Effective technical writing skills in writing policies, standard process documents, work instructions etc.
• Experience in handling internal and external Pharma audits and/or board of health inspections, including but not limited to GVP inspections is an asset.
• Experience in CAPA planning and follow-ups.
• Knowledge of current Pharmaceutical Quality Systems and Compliance standards.
• Experience working with Quality Systems including but not limited to: Document Management Systems, Change Control Systems, and Quality Management System.
• Knowledge of GxP guidelines i.e. GDP (Good Documentation Practices), GMP (Good Manufacturing Practices), GCP (Good Clinical Practice), Health Canada GVP (Good Pharmacovigilance Practices), as well as ASQ quality standards, and ISO standards.
• Bilingual (French/English) is an asset.
• Ability to multi\xe2\x80\x90task and balance day\xe2\x80\x90to\xe2\x80\x90day quality operations with tight timelines.
• Must be detail and process oriented.
• Strong interpersonal and decision\xe2\x80\x90making skills.
• Excellent written and verbal English communication skills; fluent in quality terminology.
• Team player with the ability to collaborate productively.
• Willing and able to work independently and in a collaborative team setting.

\xe2\x80\x9cAt Bayshore Healthcare, our commitment to Equity, Diversity & Inclusion is our strength. This is how we bring our vision of being the difference in the lives of those we care for, work with and in our communities. We have a great sense of pride in creating a culture of belonging, where individual differences are embraced and celebrated, through programs, resources and policies that support each individuals purpose, potential and wellbeing.\xe2\x80\x9dBayshore operates in accordance with the Accessibility for Ontarians with Disabilities Act, and applicable Provincial Human Rights Codes.

Bayshore HealthCare