Verified Job
IT / Software / Data Analyst
QA Systems Analyst- job post High Ground Medica Inc.
IT / Software / Data Analyst
#758718
Remote / WFH
High Ground Medica Inc.
Job Description
Full job description
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.
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.
