Analyst, Quality Control

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. The Analyst, Quality Control, plays a vital role in the analytical testing and quality assurance of raw materials, in‑process samples, and finished pharmaceutical products. This position ensures data accuracy, regulatory compliance, and operational excellence in accordance with GMP and company standards. The Analyst, Quality Control will support method validation, equipment qualification, and continuous improvement initiatives, contributing directly to the company’s mission to deliver safe and effective medicines to market. Please note this position requires full‑time on‑site presence. Key Responsibilities Testing & Analysis Perform laboratory tests on raw materials, in‑process control samples, packaging materials, finished products, and stability samples, particularly APIs and finished dosage forms, in accordance with approved SOPs. Utilize analytical equipment including HPLC, UHPLC, GC, UV-Vis, FTIR, viscosity, osmolality, titration setups, and others to assess product quality. Ensure complete traceability and accurate documentation of all raw data, calculations, and results in compliance with ALCOA+ and GMP principles. Accurately calculate and analyze data, ensuring raw data, test controls, and monitoring records are properly documented. Maintain accuracy and efficiency in testing, documenting results in compliance with GMP and GLP standards. Assist the QC Manager and Equipment & Systems Specialist in performing operational qualification (OQ) and performance qualification (PQ) of laboratory equipment in collaboration with suppliers. Support the development and validation of analytical methods for new products and processes. Continuously identify and propose opportunities to optimize instrument performance by refining validated parameters or adjusting system setups in accordance with GMP principles. QC Procedures, SOPs, and Process Management Develop and compile SOPs for new instruments and procedures, including OOS handling, analytical method validation, verification, technical transfers, and stability testing. Conduct investigations and root cause analyses for deviations, out‑of‑spec results, and product complaints. Support the QC Manager in OOS investigations, non‑conformance reports, CAPAs, and complaint management. Initiate QC‑related change controls and prepare written procedures, including SOPs and analytical protocols. Contribute to the implementation and continuous improvement of QC processes and quality systems. Ensures that all testing activities, observations, and results are accurately documented and maintained to uphold data integrity, traceability, and regulatory compliance. QC Documentation and Data Integrity Maintain accurate and compliant laboratory records, including test data, logbooks, and electronic entries. Review and evaluate test results to ensure they meet specifications. Prepare and review Certificates of Analysis (COA) for raw materials, and finished products. Assist Equipment & Systems Specialist and QC Manager in implementing quality‑related software systems, particularly LIMS and LabX. Manage laboratory workflows and data through LIMS to ensure seamless operations and data retrieval. Assist Equipment & Systems Specialist in documentation of QC equipment qualifications, calibration, and maintenance. Training, Support & Cross‑Function Collaboration Collaborate with Production, Quality Assurance, R&D, and Regulatory Affairs teams to ensure alignment on quality objectives and timely product release. Support internal quality audits and external inspections, ensuring compliance with regulatory standards and inspection readiness. Provide technical support to cross‑functional teams as needed. Review peer's work to ensure compliance and quality. Stay updated on industry trends, regulatory changes, and new technologies in the pharmaceutical field. Participate in training sessions and continue to develop materials for training new QC staff. Occupational Health and Safety Comply with workplace policies and procedures pertaining to environmental health and safety (EHS). Adhere to company policies, procedures, and regulations for maintaining a clean and safe work environment, including work areas, instrumentation, and testing materials. Qualifications Education M.S., B.S., or Technological degree, or a degree in Chemistry, Biochemistry, Pharmacy, or a related scientific field Experience 3–5 years of experience in GMP QC laboratory or similar pharmaceutical production settings Strong understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulatory requirements (FDA, EMA, ICH). Hands‑on experience with analytical instruments such as HPLC, GC, IR, UV-Vis spectrophotometry, and other laboratory equipment. Experience in sterile or aseptic manufacturing QC environment. Experience with LIMS for managing laboratory data, sample tracking, and documentation processes is preferred. Experience with analytical method validation and/or transfer is strongly preferred. Proficient in Microsoft Office (Word, Excel, Outlook) and laboratory/business software (e.g., OpenLab, Empower). Experience working in ISO‑17025 environment is an asset. Personal Competencies Strong oral and written communication skills; able to maintain confidentiality and interact effectively with internal teams and external stakeholders. Excellent attention to detail, critical thinking, and problem‑solving skills in a regulated laboratory environment. Committed to continuous learning and staying current with emerging technical and regulatory information. Adaptable, flexible, and forward‑thinking in applying technical knowledge to evolving laboratory processes. Effective time management and prioritization skills in a fast‑paced laboratory setting. Works independently and collaboratively to achieve team and organizational objectives. Working Conditions On‑site presence is required; work in laboratory and office settings with occasional exposure to production environment. Ability to perform occasional moderate physical activity (standing, walking, lifting, keyboarding). Ability to move/lift laboratory instruments up to 25 kg when required. Successful completion of company‑required vision assessment (e.g., Ishihara) for color‑critical analyses. Occasional evening or weekend support during planned systems maintenance or instrument qualification events. Required travel between Edmonton API sites. Additional Required Documents to Support Application Applications submitted without a resume AND cover letter will not be reviewed. Successful candidates will require their credentials to be evaluated by World Education Services or the International Qualifications Assessment Service (IQAS). Successful candidates will be subjected to vision assessment (e.g., Ishihara or equivalent) due to color‑critical analyses and visual readings. 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 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 #J-18808-Ljbffr