Administrator, Quality Assurance

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.

Administrator, Quality Assurance will support the QA Activities such as Document Record Management, Training activities, and other quality systems activities for QA. Personnel will be round of in supporting Quality System Management activities, such as change in change control, risk assessment, operational and administrational work.

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

Key Responsibilities, Include But Are Not Limited To

QA Oversight

• Perform, assess, review and approves deviation investigation and CAPA implementations
• Able to handle and lead root cause analysis and uses appropriate tools for determining the most probable root cause(s).
• Able to perform and implement a CAPA determined through the investigation results.
• Quality oversight in Quality Systems pertaining to Incident (Deviation), Investigation, CAPA and Nova- RM, and FP applications.
• Maintain QA compliance with company and regulatory standards.
• Support Document Record Management and change controls processes/ activities

Document & Records Support

• Process and routing of controlled quality documents (SOPs, Batch Records, Specifications, protocols) for distribution, review and approval as directed.
• Execute day-to-day tasks within the electronic Quality Management System (eQMS), including document formatting, uploading, and archiving.
• Assist in organizing physical and electronic archives to ensure files are accurately indexed, secure, and retrievable.

Training Program Support

• Perform Administrator duties in the Learning Management System (LMS) in support of QA DRM and Training, including activities such as maintaining and updating training items and users in coordination with department managers and QMS requirements.
• Prepare training materials and aid others in creation of training material in the Learning Management System (LMS).

Risk Analysis and QA Systems

• Have a broad understanding in risk analysis and mitigation – FMEA, HAZOP etc.
• Detail oriented- in performing the impact assessment, change control, investigation details, determination of CAPA and ensure final report compliance.
• Participate in the development and establishment of Quality Management Systems.

Data Review and Approval

• Review and approve analytical data for Raw Materials and Products– chemistry or microbiological testing for accuracy and completeness in the electronic systems.
• Support the deviation investigation related to Quality Control and Microbiology. (OOS, OOT, etc.)
• Support equipment calibration/ maintenance investigations as required.
• Responsible for review of GMP documentation – Master batch records, specifications, test methods, and sampling / labelling.
• Review and approve batch related documentation for raw materials, intermediates and finished products.
• Support assignment of lot disposition ensuring all testing requirements and manufacturing records are reviewed in compliance to GMP standards.

Collaboration and Support

• Provide guidance and training to QA Associates and other Departments
• Write and review and approve SOP’s/ WI’s if required.
• Help maintain archive documentation and retrieval.
• Provide QA operational support in different QA initiatives.
• Participate and contribute to audit inspections (Internal and External) in terms of QA documentation as necessary.
• Collaborate with Operational teams, Clients, stakeholders for any projects or requirements

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

Education

• Minimum of bachelor’s degree in engineering and/or information technology, life sciences, or a related field

Experience

• 3+ years of QA experience in the pharmaceutical or medical device industry
• At least 3 years of experience required in handl