Specialist, Compliance

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.

We are seeking a detail-oriented Specialist, Compliance to support pharmaceutical manufacturing operations s role is responsible for supporting and maintaining GMP compliance within API and sterile injectable manufacturing operations through effective production documentation, deviation and change-control management, and coordination of equipment and process qualification activities. The role partners with Production, Quality Assurance, Engineering, Validation, Quality Control, and Technical Operations to ensure manufacturing activities are executed according to approved procedures and are fully documented, traceable, and inspection ready.

These responsibilities align with GMP expectations for production documentation, deviation management, change evaluation, and qualification of facilities and equipment.

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

• Create, revise, review, and maintain GMP production documents for API and sterile injectable manufacturing processes, including master batch records, batch manufacturing records, batch packaging records, SOPs, work instructions, equipment operating procedures, cleaning procedures, logbooks, checklists, forms, and production templates.
• Develop production documentation for manufacturing processes such as dispensing, solution preparation, compounding, filtration, aseptic processing, filling, lyophilization, terminal sterilization, autoclave operations, equipment cleaning, line clearance, environmental monitoring support, and material reconciliation.

• Prepare and maintain equipment-related documentation, including equipment operation and cleaning procedures, equipment logbooks, setup and teardown instructions, calibration and maintenance documentation, status-labeling requirements, and equipment-use records.
• Verify that new, modified, or relocated equipment and facilities have the required qualification, calibration, preventive maintenance, cleaning, and operational documentation before use in GMP manufacturing.

• Ensure production documents accurately reflect approved process parameters, critical process steps, in-process controls, sampling requirements, acceptance criteria, hold times, alarm responses, and data-integrity expectations.
• Review completed production records, equipment logbooks, and associated manufacturing documentation for completeness, accuracy, traceability, Good Documentation Practices, and compliance with approved procedures.
• Identify documentation errors, omissions, unexplained discrepancies, and process-related compliance gaps; coordinate their assessment and ensure timely correction through the appropriate quality-system process.

• Initiate, document, coordinate, and track production-related deviations, incidents, nonconformances, and atypical events through investigation and closure.
• Support deviation investigations by collecting batch records, equipment history, operator statements, electronic data, environmental or process data, maintenance records, and other relevant evidence.
• Participate in root-cause analysis, product-impact assessment, risk assessment, and development of corrective and preventive actions for production deviations

• Prepare, review, and implement change controls affecting processes, equipment, facilities, utilities, materials, batch records, SOPs, production parameters, cleaning methods, and manufacturing systems.
• Assess the potential impact of proposed changes on product quality, sterility assurance, validated state, regulatory commitments, qualification status, training requirements, and ongoing manufacturing operations.
• Coordinate implementation activities for approved changes, including document…