Specialist, Quality Control

Applied Pharmaceutical Innovation (API) brings life-saving research to the real world by helping life science innovators bridge the gap between academic research and commercial product development. We are driven, compassionate, and laser focused on making a dramatic positive impact with everything we undertake.

When you join API, you are part of a rapidly growing team that is creating collaborative opportunities to commercialize Canadian life sciences discoveries, increasing the amount of commercial research and development in the country, and supporting Alberta as a key pillar in Canada’s life sciences sector.

The Specialist, Quality Control - Equipment & Systems is responsible for managing the lifecycle, qualification, and technical support of analytical laboratory instruments and computerized systems within the QC laboratory. The role ensures equipment readiness, regulatory compliance, and data integrity in alignment with GMP, pharmacopeial, and corporate standards. The Specialist also supports method transfer and validation activities and serves as a key technical resource during audits and inspections. This role also involves LAB HSE responsibilities and serves as backup for Lab Analyst.

Please note this position requires full-time on-site presence.

This is a temporary full-time position for a 20-month term covering a maternity leave, with the possibility of extension.

Key Responsibilities

Equipment Management & Qualification

• Maintain ownership of the equipment inventory for QC laboratory instruments (e.g., FTIR, UV-Vis, HPLC/GC, particle size analyzers, pH/conductivity meters, balances, viscometers, etc.).
• Lead and document installation, qualification (IQ/OQ/PQ), calibration, and maintenance activities.
• Troubleshoot instrument failures and coordinate vendor service to minimize downtime.
• Author and maintain SOPs, URS, qualification protocols, calibration plans, and lifecycle documentation.
• Ensure all equipment remains in a qualified and GMP-compliant state in accordance with USP, Ph. Eur., 21 CFR Part 11, and internal quality standards

Inventory Management

• Maintain and monitor laboratory inventory, including reagents, standards, consumables, and spare parts, ensuring appropriate stock levels.
• Coordinate with Procurement and QA to ensure timely replenishment and traceability of critical materials.
• Track lot numbers, expiry dates, and storage conditions to ensure compliance with GMP and data integrity standards.
• Support equipment spare parts inventory management and ensure alignment with preventive maintenance schedules.
• Assist in periodic reconciliation and audit of lab materials inventory, identifying obsolete or expired items for proper disposal.

Computerized System Administration

• Act as system owner or subject matter expert for LIMS, OpenLab CDS, and LabX platforms.
• Manage user access, permissions, audit trails, data backups, and periodic reviews.
• Participate in system upgrades, change control, and validation.
• Experience with MassHunter is considered a strong asset.

Analytical Method Transfer & Validation

• Support or lead analytical method transfer and validation activities (compendial and non-compendial).
• Draft, execute, and finalize validation and transfer protocols and reports in alignment with ICH Q2/Q14, pharmacopeial, and internal requirements. Collaborate with R&D, manufacturing, and external partners during technical transfers.
• Perform impact and gap assessments for new methods or technology introductions.

Documentation & Compliance

• Maintain complete and accurate equipment/system files, calibration certificates, deviation/CAPA records, and validation/qualification reports.
• Act as SME during internal audits and regulatory inspections (Health Canada, FDA, EMA, etc.).
• Ensure alignment with data integrity (ALCOA+), corporate governance, and electronic record requirements.

HSE Lab Responsibility

• Ensure safe handling, storage, and disposal of laboratory chemicals, reagents, and waste in compliance with HSE and environmental regulations.
• Monitor laboratory conditions and report any unsafe behaviors, near misses, or potential hazards to management.
• Participate in risk assessments, safety inspections, and corrective/preventive action plans related to lab safety.
• Promote and maintain adherence to PPE (Personal Protective Equipment) requirements and chemical hygiene plans.
• Support training and awareness initiatives for laboratory staff on HSE best practices and emergency response procedures.

Training, Support & Cross-Function Collaboration

• Train QC staff on instrument operation, system workflows, and data integrity practices. Serve