Quality Regulatory Affairs of Medical Devices jobs

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 require flexibility to support audits and production schedules.

· Lifting/pushing/pulling up to 25lbs, and direct contact with alcohol/chlorine based disinfectant agents

· Possible exposure to chemicals, machinery, or equipment.

Additional Required Documents to Support Application

· Applications submitted without a resume AND cover letter will not be reviewed.

Perks and Benefits at API

Comprehensive Health Coverage: At API, we prioritize the well-being of our employees. We offer a comprehensive health coverage plan. Our premiums are 100% covered, ensuring that you and your dependents receive the necessary healthcare support.

Retirement Savings: API offers a RRSP Matching Program. Employees may be eligible to participate, with API matching of contributions up to 1–3% of base salary, in accordance with program terms.

Professional Development Opportunities: We foster a culture of continuous learning and growth. API provides access to various professional development opportunities, including training programs, workshops, conferences, and certifications. We encourage employees to enhance their skills, broaden their knowledge, and stay updated with the latest advancements in the life sciences industry.

Collaborative and Inclusive Environment: At API, we believe in the power of collaboration and diversity. We foster an inclusive work environment that values and respects individuals from all backgrounds. We promote teamwork, open communication, and a supportive atmosphere where everyone's contributions are valued.

Generous Paid Time Off: We understand the importance of taking time off to recharge and maintain a healthy work-life balance. API offers a generous paid time off (PTO) policy that includes vacation days, medical/personal days, and holidays. We encourage our employees to prioritize their well-being and enjoy quality time away from work.

Green Transit Allowance: Employees based out of an office are eligible to enroll in our green transit program, which promotes the use of environmentally friendly modes of transportation. By participating in the program, you commit to making green transit your primary mode of transportation for at least 75% of your commute to and from work. Green transit includes walking, biking, carpooling, and public transportation.

Work From Home: Eligible employees are entitled to 20 Work from Home days, this is subject to job function, company needs, and manager approval.

How to Apply

Interested applicants must submit a resume and cover letter expressing their interest in the position and why they believe they are a strong candidate.

We appreciate all applicants' interest and will only contact those selected for interviews.

If you have any questions about the application process or require accommodations during the hiring process, please contact careers@appliedpharma.ca.

Our team, clients, and stakeholders come from a variety of backgrounds. In recruiting for our team, we welcome the unique contributions that all people bring to the workplace in terms of varied lived experiences, education, culture, gender, race, sexual orientation, religious or ethnic background, neurodiversity, and cognitive and physical ability.

Before employment, successful candidates will be required to meet the requirements of a pre-employment screening, which includes background reference checks, educational credential verification, and criminal reference checks.

This position will remain open until filled.

Work Location: In person