Quality Control Systems Specialist – Lab Equipment

API (Applied Pharmaceutical Innovation); Edmonton; On-site; CAD 70,000 - 95,000; Full time

Benefits offered by this job

Health Coverage

RRSP Matching

Professional Development Opportunities

Generous PTO

Green Transit Allowance

Work From Home days

Job summary

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.

Responsibilities

• 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.

Skills

GMP QC

IQ/OQ/PQ

LIMS OpenLab CDS

LabX

MassHunter

Audit readiness

Documentation

Vendor/Service contracts

Data integrity

Instrument troubleshooting

Education

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

Tools

LIMS

OpenLab CDS

LabX

Empower/MassHunter

Job description

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.