Specialist, Quality Assurance

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.

This role is responsible for managing document control and training records within the electronic Quality Management System (QMS) and maintaining a paper-based backup for business continuity. The position supports colleagues with all activities related to Document and Records Management (DRM) and training.

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

Key Responsibilities, Include But Are Not Limited To

• Performs Document and Records Management (DRM) processing, training processing and associated activities for the operation and maintenance of the electronic (and paper-based business continuity) processes of DRM and Training.
• Maintain the QA document control archive area.
• Support activities for QMS training and general GMP training.
• Reinforce GMP compliance through maintenance and ongoing continuous improvement of the QMS system for document control and training and associated procedures.
• Support non-conformance investigation by providing document control and training support.
• Support efforts to improve work cycle time, identify and minimize cost of quality in area of accountability.
• Identify areas in need of process improvement, optimization, and development.
• Participate in the resolution of non-conformances pertaining to Document Control and Training processes and procedures.
• Support assessment of technical investigations adequacy and solutions pertaining to area of responsibility.
• Prepare new and revise existing procedures in area of accountability.
• Reviews all procedures for formatting and may review other functional team's procedures for content. Maintain process flow charts in area of accountability.
• Support internal, external, and regulatory audits of the QMS.
• Maintain awareness of project meetings and emerging issues to provide proactive support.
• Provide support as a quality representative for assigned projects to assist project teams with respect to Document Control and Training and process flows.
• Assist in maintenance and provide support to other activities and aspects (modules) of the QMS as necessary.
• Assists in preparation of data and record compilation and assessment for Quality Management Review and other quality reporting content as necessary.
• Identify and communicate risks and opportunities.
• Participate in continuous improvement teams to address quality improvement opportunities.
• Conduct activities in accordance with all required corporate and departmental QMS requirements, GMP, and customer requirements.
• Ensure responsibilities are carried out in accordance with API GMP policies, SOPs, ethical and professional values.
• Apply team effectiveness skills and initiative to support, collaborate and interact with colleagues to achieve goals of the team and to be personally effective in the individual area of accountability.
• May be assigned other associated activities as requested.

Qualifications - (Education, Certification, Degree, Skills, Knowledge, Etc.)
Education

• Minimum of Bachelor degree in the related field.

Experience

• 3-5 years of experience in the related field.
• Prior experience with pharmaceutical or medical device audits is preferred.

Personal Competencies

• Strong attention to detail, organizational skills, and ability to manage multiple priorities.
• Excellent communication and collaboration skills with a proactive, compliance-focused mindset.
• Experience with electronic Quality Management Systems (QMS) and document control processes.
• Solid understanding of GMP regulations and training management requirements.
• Ability to support audits, maintain controlled documents, and ensure accurate training records.
• Proficiency in MS Office and familiarity with technical writing for SOPs and process documentation

Working Conditions

• Required travel between Edmonton API sites.
• This position requires you to be on site.

Additional Required Documents To Support Application

• Applications submitted without a resume AND cover letter will not be reviewed.
• Please attach relevant designations or certifications.
• Successful candidates will require their credentials to be evaluated by World Education Services or the International Qualifications Assessment Service (IQAS).

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.

Payment in Lieu of Pension: API provides an additional 15% of your annual base salary, as an alternative to traditional pension benefits.

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 10 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

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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.

Applicants with education credentials earned outside of Canada should have their credentials evaluated by World Education Services or the International Qualifications Assessment Service (IQAS).

Application Deadline: December 5, 2025