Specialist, Quality Control - Equipment & Systems

API • Edmonton, AB

1d • Onsite

About The Position

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

Requirements

• B.S, M.S, or Tech degree in Chemistry, Biochemistry, Pharmacy or a related scientific field.
• 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
• Experience with LIMS integration or digital lab initiatives.
• Vendor/service contract oversight experience.
• Experience working in ISO-17025 environment.
• Lean Six Sigma or equivalent process excellence certification.
• Strong problem-solving and root-cause analysis skills.
• Excellent documentation and technical writing in a regulated environment.
• High attention to detail, data integrity, and critical thinking.
• Effective communication and collaboration across cross-functional teams.
• Ability to prioritize and meet deadlines in a fast-paced environment.
• Continuous improvement mindset and adaptability to new technologies.

Nice To Haves

• MassHunter is an asset.
• Experience in analytical method validation and/or transfer preferred.
• Lean Six Sigma or equivalent process excellence certification.

Responsibilities

• 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
• 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.
• 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.
• 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.
• 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.
• 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.
• Train QC staff on instrument operation, system workflows, and data integrity practices.
• Serve as a backup QC Analyst when required, including performing routine testing aligned with training and qualification.
• Work closely with Production, QA, CSV, IT, and Procurement to ensure compliant, efficient lab operations.
• Contribute to continuous improvement, digitalization, and Lean lab initiatives.

Benefits

• Comprehensive health coverage plan with 100% premium coverage for employees and dependents.
• RRSP Matching Program with API matching contributions up to 1–3% of base salary.
• Access to professional development opportunities, including training programs, workshops, conferences, and certifications.
• Generous paid time off (PTO) policy including vacation days, medical/personal days, and holidays.
• Green Transit Allowance for employees who use environmentally friendly transportation for at least 75% of their commute.
• 20 Work From Home days for eligible employees, subject to job function, company needs, and manager approval.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level