Specialist, Quality Control - Equipment & Systems

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 Specialist, Quality Control - Equipment & Systems is responsible for managing the lifecycle, qualification, and technical support of analytical laboratory instruments and computerized systems within the QC laboratory. The role ensures equipment readiness, regulatory compliance, and data integrity in alignment with GMP, pharmacopeial, and corporate standards. The Specialist also supports method transfer and validation activities and serves as a key technical resource during audits and inspections. This role also involves LAB HSE responsibilities and serves as backup for Lab Analyst.

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

This is a temporary full-time position for a 20-month term covering a maternity leave, with the possibility of extension.

Key Responsibilities, include but are not limited to:

Equipment Management & Qualification

• Maintain ownership of the equipment inventory for QC laboratory instruments (e.g., FTIR, UV-Vis, HPLC/GC, particle size analyzers, pH/conductivity meters, balances, viscometers, etc.).
• Lead and document installation, qualification (IQ/OQ/PQ), calibration, and maintenance activities.
• Troubleshoot instrument failures and coordinate vendor service to minimize downtime.
• Author and maintain SOPs, URS, qualification protocols, calibration plans, and lifecycle documentation.
• Ensure all equipment remains in a qualified and GMP-compliant state in accordance with USP, Ph. Eur., 21 CFR Part 11, and internal quality standards

Inventory Management 

• Maintain and monitor laboratory inventory, including reagents, standards, consumables, and spare parts, ensuring appropriate stock levels.
• Coordinate with Procurement and QA to ensure timely replenishment and traceability of critical materials.
• Track lot numbers, expiry dates, and storage conditions to ensure compliance with GMP and data integrity standards.
• Support equipment spare parts inventory management and ensure alignment with preventive maintenance schedules.
• Assist in periodic reconciliation and audit of lab materials inventory, identifying obsolete or expired items for proper disposal.

 Computerized System Administration

• Act as system owner or subject matter expert for LIMS, OpenLab CDS, and LabX platforms.
• Manage user access, permissions, audit trails, data backups, and periodic reviews.
• Participate in system upgrades, change control, and validation.
• Experience with MassHunter is considered a strong asset.

Analytical Method Transfer & Validation

• Support or lead analytical method transfer and validation activities (compendial and non-compendial).
• Draft, execute, and finalize validation and transfer protocols and reports in alignment with ICH Q2/Q14, pharmacopeial, and internal requirements. Collaborate with R&D, manufacturing, and external partners during technical transfers.
• Perform impact and gap assessments for new methods or technology introductions.

 Documentation & Compliance

• Maintain complete and accurate equipment/system files, calibration certificates, deviation/CAPA records, and validation/qualification reports.
• Act as SME during internal audits and regulatory inspections (Health Canada, FDA, EMA, etc.).
• Ensure alignment with data integrity (ALCOA+), corporate governance, and electronic record requirements.

HSE Lab Responsibility

• Ensure safe handling, storage, and disposal of laboratory chemicals, reagents, and waste in compliance with HSE and environmental regulations.
• Monitor laboratory conditions and report any unsafe behaviors, near misses, or potential hazards to management.
• Participate in risk assessments, safety inspections, and corrective/preventive action plans related to lab safety.
• Promote and maintain adherence to PPE (Personal Protective Equipment) requirements and chemical hygiene plans.
• Support training and awareness initiatives for laboratory staff on HSE best practices and emergency response procedures.

 Training, Support & Cross-Function Collaboration

• Train QC staff on instrument operation, system workflows, and data integrity practices. Serve as a backup QC Analyst when required, including performing routine testing aligned with training and qualification.
• Work closely with Production, QA, CSV, IT, and Procurement to ensure compliant, efficient lab operations.
• Contribute to continuous improvement, digitalization, and Lean lab initiatives.

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

Education

• B.S, M.S, or Tech degree in Chemistry, Biochemistry, Pharmacy or a related scientific field.

Experience:

• 3–5 years’ experience in GMP QC laboratory or pharmaceutical production.
• Strong knowledge of GMP, GLP, and regulatory standards (FDA, EMA, ICH).
• Proficient with analytical instruments (HPLC, GC, IR, UV-Vis) and lab software (LIMS, OpenLab, Empower, LabX); MassHunter is an asset.
• Experience in analytical method validation and/or transfer preferred.
• Familiarity with pharmacopeial standards and QC workflows.
• Proficient in Microsoft Office and capable of learning new systems
• Experience with LIMS integration or digital lab initiatives.
• Vendor/service contract oversight experience.
• Experience working in ISO-17025 environment.
• Lean Six Sigma or equivalent process excellence certification.

Personal Competencies

• Strong problem-solving and root-cause analysis skills.
• Excellent documentation and technical writing in a regulated environment.
• High attention to detail, data integrity, and critical thinking.
• Effective communication and collaboration across cross-functional teams.
• Ability to prioritize and meet deadlines in a fast-paced environment.
• Continuous improvement mindset and adaptability to new technologies.

Working Conditions:

• Ability to perform occasional moderate physical activities (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 for planned maintenance or instrument qualification.
• On-site presence required, work in laboratory and office settings with occasional exposure to production environment.
• 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 subject to vision assessment (e.g., Ishihara or equivalent) due to colour-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.

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.

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

This position will remain open until filled.