Technologist Quality Control

Applied Pharmaceutical Innovation (API) brings lifesaving 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.

Technologist Quality Control plays a critical role in ensuring product quality and regulatory compliance by performing a range of analytical tests on raw materials inprocess samples and finished pharmaceutical products particularly drug substances and drug products utilizing techniques such as HPLC GC UVVis FTIR and others the Technologist Quality Control ensures accurate GMPcompliant testing and documentation. The role supports equipment qualification method transfer data integrity through LIMS development of Quality Control documentation and continuous improvement initiatives.

** Please note this position requires fulltime onsite presence.

Key Responsibilities include but are not limited to:

Testing & Analysis:

• Perform laboratory tests on raw materials inprocess materials packaging materials and finished products particularly APIs and finished dosage forms following established SOPs.
• Utilize analytical techniques such as HPLC UHPLC GC UVVis 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.

Documentation & Compliance:

• 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 qualityrelated 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.

Quality Control Procedures:

• 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 outofspec results or complaints.
• Support the QC Manager in OOS investigations nonconformance (NC) reports CAPAs and product complaints.
• Initiate QCrelated 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.

Team Collaboration & Communication:

• 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 crossfunctional teams as needed.
• Review peers work to ensure compliance and quality.

Training & Development:

• 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 Certification Degree Skills Knowledge etc.

Education

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

Experience:

• Strong knowledge of analytical testing in GMP environment
• Handson experience with analytical instruments such as HPLC GC IR UVVis spectrophotometry and other laboratory equipment.
• Strong understanding of Good Manufacturing Practices (GMP) Good Laboratory Practices (GLP) and other regulatory requirements (FDA EMA ICH).
• 3 5 years of experience in GMP QC laboratory or similar pharmaceutical production settings is preferred.
• Experience with LIMS for managing laboratory data sample tracking and documentation processes is preferred.
• Experience working in ISO17025 environment is an asset.

Personal Competencies:

• 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 fastpaced 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 forwardthinking.
• Committed to continuous learning reviewing scientific literature and staying current with new technical and scientific information.
• Proficiency in Microsoft Office applications (Word Excel Outlook) and businessrelated software such as Open Lab Empower or similar applications with the ability to learn companyspecific software.

Working Conditions:

• This position requires onsite presence.
• Exposure to production environment
• Work in production and office settings.

Additional Required Documents to Support Application

• Applications submitted without a resume AND cover letter will not be reviewed.

Perks and Benefits at API

Comprehensive Health Coverage: At API we prioritize the wellbeing 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 worklife 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 wellbeing 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 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 preemployment screening which includes background reference checks educational credential verification and criminal reference checks.

Application Deadline: May 6 2025