Job Summary:
The QA Systems Analyst is a temporary, fixed-term role (approximately 3–6 months with potential to lead to a permanent position) established to bring High Ground Medica's (HGM) computerized systems and electronic records into a validated, secure, and inspection-ready state, in alignment with QMS_COR_009_SOP – Computerized Systems & Electronic Records Control. Working across the Quality Management System (QMS), the analyst ensures the Monday.com work-management platform is accurately maintained, the SharePoint document-control environment is validated and configured to GxP requirements, and all digital systems are secured through ALCOA+ data-integrity controls — access management, audit trails, and backup/restore. The role applies a risk-based lifecycle approach (GAMP 5), reports to the Quality Assurance Person (QAP) with day-to-day coordination through the QAQC Lead, and works closely with System and Process Owners and IT / external service providers. Success is a complete and current Computerized System Inventory, executed computerized system validation (CSV) deliverables for GxP systems, and closed remediation actions that support HGM's GMP certification and EU-export readiness.
Key Responsibilities
Computerized System Inventory & Risk Classification
a) Build and maintain the Computerized System Inventory (QMS_COR_009_INV01), recording each GxP system's unique System ID, version, supplier, GxP impact, System/Process Owner, validation status, and next periodic-review date.
b) Complete GxP impact assessments (QMS_GOV_003_CKL01) for each system and classify impact as High/Critical, Medium, or Low to scale the validation effort (GAMP 5).
c) Keep the inventory current as systems are added, changed, or retired, and route revisions for QAQC approval.
Monday.com Administration & Data Integrity
a) Ensure Monday.com boards, items, and statuses accurately and contemporaneously reflect QMS activities (documents, change requests, risk assessments, CAPAs, periodic reviews, and training).
b) Align board and workflow structure with approved QMS processes; verify entered data is accurate, attributable, and traceable.
c) Configure and document user roles and access on a least-privilege basis; remove or amend access promptly on role change or departure.
d) Where Monday.com holds or drives GxP decisions, assess it under CSV and data-integrity controls, including activity log/audit trail, export, and backup arrangements.
SharePoint Document-Control Validation
a) Validate the SharePoint document-control configuration against QMS_GOV_004_SOP (Document, Label & Record Management) and the SharePoint configuration guidance — version control, approval workflow, permissions, retention, and audit history.
b) Verify controlled documents are current, correctly issued, access-restricted, and retrievable throughout the required retention period.
c) Execute and record IQ/OQ verification of SharePoint GxP functions (versioning, audit trail, permissions) within the applicable validation deliverables.
Computerized System Validation (CSV) Execution
a) Prepare and execute Validation Plans (QMS_COR_009_PLA01), Test Protocols / IQ-OQ-PQ (QMS_COR_009_PRO01), Traceability Matrices (QMS_COR_009_MAT01), and Final Reports (QMS_COR_009_REP01), proportionate to system risk.
b) Verify data-integrity controls during testing: access control, audit trail, calculations, interfaces, and backup/restore.
c) Document deviations encountered during execution; ensure unresolved critical items prevent release of the system for GxP use.
d) Perform documented gap assessments of legacy systems and apply risk-based interim controls where required.
Access Control & System Security
a) Implement unique user IDs and role-based, least-privilege access across GxP systems, with documented authorization.
b) Restrict and segregate administrator rights; conduct and document periodic user-access reviews.
c) Verify physical and logical security of servers, controllers, and endpoints supporting GxP systems.
Audit Trails, Backup & Disaster Recovery
a) Confirm audit-trail functionality is enabled and protected from alteration; perform risk-based audit-trail reviews.
b) Verify scheduled backups and perform documented restore tests; confirm disaster-recovery / business-continuity provisions for High and Medium impact systems.
Data Integrity (ALCOA+), Spreadsheets & Records
a) Ensure GxP electronic records meet ALCOA+ principles across their lifecycle; validate and lock GxP spreadsheets (verified formulas, protected cells, template control).
b) Verify time synchronization, retention/archiving, and controlled data migration on upgrade or retirement.
c) Manage suspected data-integrity issues as deviations in accordance with QMS_GOV_007_SOP.
Change Control, Periodic Review & Supplier Oversight
a) Route system and configuration changes through QMS_GOV_006_SOP; assess impact on the validated state and perform regression testing / partial revalidation as determined by risk.
b) Schedule and execute periodic reviews; track resulting actions to closure and update the inventory.
c) Assess suppliers and SaaS providers; ensure agreements define availability, security, backup, data ownership, and incident notification, consistent with EU GMP Annex 11.
Reporting, Documentation & Handover
a) Provide regular status updates to the QAP and QAQC Lead on validation progress, data-integrity risks, and open actions.
b) Maintain complete, accurate, and traceable records of all validation and security activities.
c) At contract end, deliver a documented handover: current Computerized System Inventory, completed validations, residual/open actions, and the ongoing maintenance and periodic-review schedule.
Qualifications, Knowledge & Skills
· Post-secondary education in computer/information systems, quality, life sciences, engineering, or a related field — or equivalent demonstrated experience in a regulated environment (cannabis, pharmaceutical, food, or medical device preferred).
· Working knowledge of computerized system validation and data integrity, including EU GMP Annex 11, Annex 15, ISPE GAMP 5, and PIC/S PI 041 (awareness of 21 CFR Part 11 an asset).
· Familiarity with Health Canada's Cannabis Regulations (GPP), GACP, and GMP requirements would be considered an Asset.
· Hands-on experience administering Monday.com (or a comparable work-management/project platform) and SharePoint document control / Microsoft 365 administration.
· Strong practical understanding of access management, audit trails, backup and restore, and ALCOA+ record-keeping.
· High attention to detail with strong documentation, organizational, and problem-solving skills.
· Able to work independently, prioritize effectively, and deliver defined outcomes within a fixed-term timeframe.
· Proficiency in Microsoft 365 and quality management system (QMS) tools.
Mandatory
· Must not have any criminal convictions or arrests involving drug-related offences, (a criminal record check with the RCMP will be required prior to and at the CEO's discretion to maintain the position).
· Applicants must have legal authorization to work in Canada with no restrictions.
· Must have reliable transportation as our facility is out of town.
Pay: From $70,000.00 per year
Work Location: Hybrid remote in Red Deer, AB
