Analyst, Quality Control

API • Edmonton, AB

2d • CA$75,000 - CA$95,000 • Onsite

About The Position

Applied Pharmaceutical Innovation (API) is a company dedicated to advancing life-saving research from academic discovery to commercial product development. API fosters a collaborative environment to commercialize Canadian life sciences discoveries, boost R&D in the country, and support Alberta's role in the life sciences sector. The Analyst, Quality Control is a vital role focused on ensuring product quality and regulatory compliance. This position involves performing various analytical tests on raw materials, in-process samples, and finished pharmaceutical products, including drug substances and drug products. The role also supports equipment qualification, method transfer, method validation and verification, data integrity through LIMS, development of Quality Control documentation, and continuous improvement initiatives. This is a full-time, on-site position with two vacancies.

Requirements

• M.S., B.S., or Technological degree, or a degree in Chemistry, Biochemistry, Pharmacy, or a related scientific field.
• 2-5 years of relevant experience in GMP QC laboratory or similar in pharmaceutical production settings.
• Strong knowledge of analytical testing in GMP environment is required.
• Hands-on experience with analytical instruments such as HPLC, GC, IR, UV-Vis spectrophotometry, and other laboratory equipment is required.
• Strong understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other regulatory requirements (FDA, EMA, ICH) is required.
• Proficient experience in MS Office Suite and business-related software such as Open Lab, Empower or similar application is required.
• Strong oral and written communication skills, with the ability to handle confidential information and frequent internal and external interactions.
• Excellent attention to detail and critical thinking.
• Ability to manage time effectively and prioritize tasks in a fast-paced environment.
• Occasional moderate physical activity, including standing, walking, lifting, and keyboarding.
• Ability to meet deadlines and troubleshoot problems efficiently.
• Ability to work independently and as part of a team to achieve organizational objectives.
• Technically adaptable, flexible, and forward-thinking.
• Committed to continuous learning, reviewing scientific literature, and staying current with new technical and scientific information.
• Required travel between Edmonton API sites.
• Successful candidates will be subject to vision assessment (e.g., Ishihara or equivalent) due to colour-critical analyses and visual readings.
• 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).

Nice To Haves

• Additional technology diploma or certificate is an asset.
• Experience with LIMS for managing laboratory data, sample tracking, and documentation processes is preferred.
• Experience working in ISO-17025 environment is an asset.

Responsibilities

• Perform laboratory tests on raw materials, in-process materials, packaging materials, and finished products, particularly APIs and finished dosage forms, following established SOPs.
• Utilize analytical techniques such as HPLC, UHPLC, GC, UV-Vis, FTIR, viscosity, osmolality, and titration to assess product quality.
• Ensure sample and data traceability throughout testing.
• Accurately calculate and analyze data to reflect raw data, ensuring test controls and monitors are properly recorded.
• Maintain accuracy and efficiency in testing, documenting results in compliance with GMP and GLP standards.
• Assist QC Manager to perform OQ, and PQ of laboratory equipment in collaboration with suppliers.
• Assist in developing and validating analytical methods for new products or processes.
• Continuously suggest optimizing instrument results by refining parameters or adjusting setups.
• Maintain accurate records of testing data, observations, and calculations in compliance with regulatory requirements and GMP standards.
• Review and evaluate test results to ensure they meet specifications.
• Prepare and review Certificates of Analysis (COA) for raw materials, intermediates, and finished products.
• Assist the 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.
• Document QC equipment qualifications, calibration, and maintenance.
• Develop and compile SOPs for new instruments and procedures, including OOS, analytical validation, verification, technical transfers, and stability testing.
• Conduct investigations and root cause analyses for deviations, out-of-spec results, or complaints.
• Support the QC Manager in OOS investigations, non-conformance (NC) reports, CAPAs, and product complaints.
• Initiate QC-related change controls and prepare written procedures, including SOPs and other protocols for analysis.
• Assist in performing OQ and PQ of laboratory equipment in collaboration with suppliers.
• Support the development and validation of analytical methods for new products or processes.
• Contribute to the implementation and continuous improvement of QC processes and quality systems.
• 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.
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level