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 Canadas 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.

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:

• 35 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.

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 everyones 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 .

Our team clients and stakeholders come from a variety of 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

Required Experience:

IC