Lead QA jobs

JOB SUMMARY
The QA Lead owns the system side of High Ground Medica's Quality Management System (QMS): the training program, document control, quality event administration, supplier qualification, the audit program, and the second-stage batch record review that readies each batch file for QAP release.

KEY RESPONSIBILITIES

1. Training Program

• Own the training file: maintain the Training Matrix, the role-based training requirements for every position, and each employee's training records under QAQC control.
• Develop and maintain training materials, competency assessments and answer keys for each effective procedure, and revise them when the procedure changes.
• Deliver or assign training, mark written competency assessments, and manage retraining after a failed assessment.
• Qualify trainers and practical-assessment evaluators, maintain Trainer Qualification Records, and reassess them periodically.
• Review completed training records for good documentation practice before a person is authorized for independent work.
• Determine the training and retraining required by change controls, deviations and CAPAs.
• Evaluate training effectiveness using deviation, audit and CAPA trends, issue the monthly controlled copy of the Training Matrix, and complete its annual review.

2. Document Control

• Administer the controlled document lifecycle: drafting, formatting to the HGM standard, review and approval routing, issue, periodic review, supersedure and archiving.
• Assign document IDs and revision numbers and keep the Document Control Register and its SharePoint structure current.
• Supply the QC Lead with current approved versions for on-site issue and confirm that superseded copies have been retrieved.
• Prepare the monthly controlled exports of GMP-relevant Monday.com logs and boards for QAP signature.

3. Quality Events

• Open and number deviation, OOS/OOT/OOE, CAPA and change control records within procedural timelines, and maintain the registers.
• Facilitate risk and impact assessments and root cause analysis, and write up investigations using evidence gathered on site by the QC Lead.
• Review contract laboratory OOS investigation reports.
• Track actions, due dates and interim controls to closure and confirm CAPA effectiveness against on-site verification.
• Trend quality events and report quality metrics for Management Review.

4. Batch Record Review

• Perform the second-stage review of each batch file after the QC Lead's on-site first review: completeness, accuracy, calculations and reconciliation, results against specification, and the status of every associated quality event.
• Return records for correction and track each correction to closure.
• Compile the batch review package and submit it to the QAP for the release decision.
• Prepare supporting documentation for the EU Qualified Person as directed by the QAP.
• Compile data for the Annual Product Quality Review.

5. Supplier & Customer Qualification

• Carry out supplier qualification: questionnaires, certificate and document review, risk assessment, supplier files and Technical Quality Agreements.
• Verify GACP and GMP documentation for B2B cannabis suppliers before material is received.
• Maintain the Approved Supplier List and Approved Customer List, monitor supplier performance, and complete the annual reconciliation against purchasing.
• Verify customer licences and permits for outbound shipments.

6. Audits & Self-Inspection

• Maintain the annual audit plan and prepare audit checklists.
• Conduct document-based and remote audits, and schedule the on-site self-inspections carried out by the QC Lead.
• Issue audit reports and track findings to verified closure.
• Coordinate readiness packages and written responses for Health Canada, GACP, EU GMP and customer audits.

7. Quality System Support

• Draft and maintain specifications, stability plans and reports, and qualification and validation protocols and reports, including computerized system validation, for execution on site.
• Administer complaint and recall records and mock recall documentation.

PERFORMANCE INDICATORS

1. Training Matrix current; no one performs a task without documented, assessed training.

2. Quality events opened and closed within the timeframes set in the governing SOPs.

3. Batch files reach the QAP complete, with no gaps left for the final review.

4. Controlled documents reviewed by their periodic review dates.

QUALIFICATIONS, KNOWLEDGE & SKILLS

1. Post-secondary education in a science, quality or regulatory discipline, or equivalent experience preferred.

2. Two to five years in quality assurance in a regulated environment (cannabis, pharmaceutical or food).

3. Working knowledge of GPP under the Cannabis Regulations and of GACP; EU GMP experience is a strong asset.

4. Demonstrated experience in document control, deviation, CAPA and change control management, and batch record review.

5. Experience building and delivering training and assessing competency.

6. Strong technical writing, with proficiency in Microsoft 365 and SharePoint; internal auditor training is an asset.

7. Able to work independently and hold deadlines without on-site supervision.

MANDATORY

1. Must not have any criminal convictions involving drug-related offences (a criminal record check with the RCMP will be required prior to hire and, at the CEO's discretion, to maintain the position).

2. Must have legal authorization to work in Canada with no restrictions.

3. Must have reliable high-speed internet and a private workspace, and be able to travel to the Oyen, AB facility when required.

Location:

• Oyen, AB (required)

Work Location: In person