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 at API. This 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.
Key Responsibilities, include but are not limited to:
GMP Manufacturing Documentation Management
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.
Equipment Documentation Management
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.
Production Record Review & Compliance
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.
Deviations, Investigations & CAPA
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
Change Control Management
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 revision, training, equipment modification, validation or qualification requirements, implementation planning, and post-implementation effectiveness checks.
Equipment Qualification Support
Support the preparation, review, routing, execution, and completion of equipment qualification documentation, including user requirement specifications, functional and design specifications, risk assessments, qualification plans, commissioning records, IQ, OQ, PQ, and qualification reports.
Coordinate with Validation, Engineering, Production, QA, and Technical Operations to ensure qualification activities are appropriately linked to approved procedures, equipment status, calibration, maintenance, cleaning, computerized systems, and manufacturing readiness.
Support qualification and validation execution by ensuring approved protocols are available, operators are trained, required records are completed contemporaneously, and deviations are documented and assessed.
Process Validation Support
Support the creation and review of process qualification and validation documentation, including validation plans, process qualification protocols, sampling plans, execution records, continued process verification requirements, deviation assessments, and final reports.
Risk Management
Participate in process and equipment risk assessments, including evaluation of critical process parameters, critical quality attributes, contamination-control risks, aseptic risks, failure modes, and operator-dependent activities.
Document Control & Records Management
Support batch record and manufacturing document issuance, reconciliation, archival, and periodic review in accordance with document-control procedures.
Maintain production compliance trackers, action-item logs, deviation and change-control status reports, qualification documentation indexes, and key performance indicators.
GMP Compliance, Audits & Inspection Readiness
Conduct routine walkthroughs of API, sterile manufacturing, warehouse, equipment, and support areas to identify documentation, procedural, equipment-status, housekeeping, and GMP compliance gaps.
Support internal audits, customer audits, regulatory inspections, and inspection-readiness activities by retrieving production records, qualification documents, deviation files, change controls, training records, and other compliance evidence.
Training & Continuous Improvement
Provide GMP, Good Documentation Practices, SOP, batch-record, deviation-reporting, and change-control training or training support for Production and related personnel.
Promote right-first-time documentation, data integrity, contamination-control practices, aseptic behaviors, and continuous improvement while ensuring production schedules are achieved without compromising product quality or patient safety.
Qualifications - (Education, Certification, Degree, Skills, Knowledge, etc.)
Education
A minimum of Bachelor degree in Chemistry, Pharmacy, or life science.
Experience:
3-5 years of experience in cGMP regulated pharmaceutical manufacturing environment on the production shopfloor
Experience in strong technical writing skills, independently create SOPs, investigate and write deviations, initiate change controls is required.
Experience in Excel and Word, including experience creating documents to be used on the manufacturing floor is a must.
Hands on experience in pharmaceutical production activities is preferred.
Personal Competencies
Strong oral and written communication.
Good interpersonal skills with the ability to interact with people at all levels with sensitivity and tact.
Ability to take direction.
Enthusiastic and willing to learn.
Working Conditions:
Required travel between Edmonton API sites.
This position requires you to be on site.
Work is performed in office and cleanroom environments.
Gowning is required for cleanroom environments.
May requir

Employment type
Full-Time (Permanent)

Work arrangement
No