Quality Control Equipment & Systems Specialist – GMP Lab

BioTalent Canada; Edmonton; On-site; CAD 90,000 - 120,000; Full time

Benefits offered by this job

Health coverage and benefits

RRSP matching

Professional development programs

Generous paid time off

Green transit allowance

Work-from-home days

Job summary

Applied Pharmaceutical Innovation (API) is seeking a Specialist, Quality Control – Equipment & Systems, to manage QC laboratory instruments and computerized systems. The role supports GMP compliance, data integrity, and method transfer during audits. On-site presence is required for the 20‑month maternity cover.

The candidate will lead installation, qualification, calibration, and maintenance activities, and collaborate with R&D, QA, and procurement to ensure qualified, compliant operations.

Qualifications

• 3–5 years’ GMP QC laboratory experience or equivalent.
• 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).
• Experience with analytical method validation and/or transfer preferred.

Responsibilities

• Manage equipment lifecycle, qualification, and support within QC lab.
• Maintain instrument inventory and calibration plans; ensure data integrity and regulatory compliance.
• Serve as SME for LIMS, OpenLab CDS, and LabX; assist in system upgrades and validation.

Skills

GMP knowledge

QC laboratory experience

Analytical instrumentation

Data integrity

Education

B.S./M.S./Tech in Chemistry/Biochemistry/Pharmacy

Tools

LIMS

OpenLab CDS

LabX

MassHunter

Job description

Applied Pharmaceutical Innovation (API) is seeking a Specialist, Quality Control – Equipment & Systems, to manage QC laboratory instruments and computerized systems. The role supports GMP compliance, data integrity, and method transfer during audits. On-site presence is required for the 20‑month maternity cover.

The candidate will lead installation, qualification, calibration, and maintenance activities, and collaborate with R&D, QA, and procurement to ensure qualified, compliant operations.