Specialist, Quality Assurance

Specialist, Quality Assurance - Document Records Management & Training Join to apply for the Specialist, Quality Assurance - Document Records Management & Training role at API. 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. Key Responsibilities 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: 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 Comprehensive Health Coverage: API prioritizes the well‑being of our employees. Our premiums are 100% covered. 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: Access to various professional development opportunities, including training programs, workshops, conferences, and certifications. Collaborative and Inclusive Environment: Inclusive work environment that values and respects individuals from all backgrounds. Generous Paid Time Off: Policy includes vacation days, medical/personal days, and holidays. Green Transit Allowance: Eligible employees can enroll in a green transit program; commitments include using environmentally friendly modes of transportation for at least 75% of commute. Work From Home: Eligible employees entitled to 10 work‑from‑home days, subject to job function, company needs, and manager approval. How to Apply Submit a resume and cover letter expressing your interest and explaining why you are a strong candidate. Only selected candidates will be contacted for interviews. For questions or accommodations during the hiring process, 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. 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 Seniority Level Mid‑Senior level Employment Type Full‑time Job Function Quality Assurance Industries Economic Programs Referrals increase your chances of interviewing at API by 2x. #J-18808-Ljbffr