Quality Control Systems Specialist – Lab Equipment

API (Applied Pharmaceutical Innovation); Edmonton; Sur place; CAD 70 000 - 95 000; Plein temps

Avantages offerts par ce poste

Health Coverage

RRSP Matching

Professional Development Opportunities

Generous PTO

Green Transit Allowance

Work From Home days

Résumé du poste

Applied Pharmaceutical Innovation (API) seeks a Specialist in Quality Control - Equipment & Systems to manage, qualify, and support QC laboratory instruments and computerized systems on-site in Edmonton. The role covers IQ/OQ/PQ, calibration, and maintenance while ensuring GMP compliance and data integrity across USP and ICH standards.

Qualifications include 3–5 years in GMP QC, strong instrument knowledge (HPLC/GC/IR/UV-Vis), and experience with LIMS/OpenLab/LabX; MassHunter is an asset.

Qualifications

• 3–5 years’ experience in GMP QC laboratory or pharmaceutical production.
• Strong knowledge of GMP, GLP, and regulatory standards (FDA, EMA, ICH).
• Proficient with analytical instruments (HPLC, GC, IR, UV-Vis) and lab software (LIMS, OpenLab, Empower, LabX). MassHunter is an asset.
• Experience in analytical method validation and/or transfer preferred.
• Familiarity with pharmacopeial standards and QC workflows.
• Proficient in Microsoft Office and capable of learning new systems.

Responsabilités

• Maintain equipment lifecycle, qualification, and technical support for QC laboratory instruments and computerized systems.
• Lead installation, IQ/OQ/PQ, calibration, maintenance; troubleshoot downtime; write/maintain SOPs and qualification documents.
• Ensure GMP compliance, data integrity, and alignment with USP, Ph. Eur., 21 CFR Part 11; support audits and inspections.
• Support lab HSE duties and act as backup QC Analyst when needed.
• Oversee system administration for LIMS/OpenLab/LabX and manage user access and backups.

Connaissances

GMP QC

IQ/OQ/PQ

LIMS OpenLab CDS

LabX

MassHunter

Audit readiness

Documentation

Vendor/Service contracts

Data integrity

Instrument troubleshooting

Formation

B.S./M.S. in Chemistry or related field

Outils

LIMS

OpenLab CDS

LabX

Empower/MassHunter

Description du poste

Applied Pharmaceutical Innovation (API) seeks a Specialist in Quality Control - Equipment & Systems to manage, qualify, and support QC laboratory instruments and computerized systems on-site in Edmonton. The role covers IQ/OQ/PQ, calibration, and maintenance while ensuring GMP compliance and data integrity across USP and ICH standards.

Qualifications include 3–5 years in GMP QC, strong instrument knowledge (HPLC/GC/IR/UV-Vis), and experience with LIMS/OpenLab/LabX; MassHunter is an asset.