Quality Assurance Officer

Transpharmation is a dynamic preclinical contract research organization that specializes in high-quality, translational drug discovery services. The company provides a friendly and team-oriented work atmosphere as well as competitive wages and benefits.

JOB SUMMARY

The Quality Assurance Officer is responsible for providing independent assurance of compliance with, regulatory requirements and company standards. This role involves conducting audits (inspections), reviewing documentation for compliance, providing training, as well as Quality Control (QC) of study data and records for studies.

DUTIES AND RESPONSIBILITIES

Key Activities

o Monitoring compliance regulatory guidelines and internal procedures:

• Maintain independence from study conduct while supporting overall quality management system effectiveness.
• Perform risk-based QA activities aligned with regulatory and organizational expectations.
• Conduct study-based inspections (study plan verifications, critical phase inspections, study data and final report inspections).
• Prepare the QA statement for inclusion in the final reports for studies.
• Conduct regular facility-based and process-based inspections.
• Document inspection findings and communicate results to Study Directors
• Track and verify effectiveness of corrective and preventative actions .
• Support qualification and monitoring of vendors and subcontractors.
• Review vendor qualification documentation for compliance.
• Quality Management System documentation:
  • Review quality management system documentation for compliance (Standard Operating Procedures, Process Guides, forms, templates).
  • Develop, approve and maintain Quality Assurance procedures and documentation, including SOPs, audit checklists, and training materials.
  • Proof reading client reports
• Regulatory Liaison: Serve as a point of contact for regulatory inspections and audits, ensuring that all necessary documentation and records are available and up-to-date.
• Maintain an equipment inventory and manage/maintain as required including purchase requests for replacements or updates. Ensuring warranties remain current
• Maintain training records and refreshers
• Other duties as assigned.

This position will liaise with all other departments on an as needed basis.

COMMUNICATION

Verbal communication is required to request and receive instructions for work, to report on activities, results, and problems. Written communication is required for accurate and detailed recording of procedures, and for completing documentation. Reading and comprehension of written procedures and manuals is essential.

WORKING CONDITIONS

ENVIRONMENT

This position will be within the office environment and includes sitting for extended periods of time.

RISK TO HEALTH

There will be the occasional exposure to small quantities of toxic irritant or corrosive chemicals. There will be exposure to zoonotic diseases. There will be occasional periods of several hours per day performing physically repetitive procedures (typing, filing etc.). There is also a potential for digital eye strain resulting from prolonged computer use.

PHYSICAL REQUIREMENTS

PHYSICAL DEMANDS

Little to no physical effort required.

PHYSICAL DEXTERITY

Visual acuity, agility, accuracy and consistency will be required.

QUALIFICATIONS

Education

• Bachelor's degree in Life Sciences (e.g., Biology, Chemistry, Pharmacology).

Experience

• 2-5 years of experience in a regulated laboratory research or testing environment
• Minimum 2 years of Quality Assurance experience in a regulated laboratory research or testing environment.
• Experience conducting and reporting audits/inspections.

Knowledge/Skills

• Strong understanding of quality management systems and documentation practices.
• Understanding of risk-based quality management approaches.
• Excellent attention to detail and strong analytical skills.
• Effective communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Proficiency in Microsoft Office and quality management software.
• Familiarity with electronic data capture systems and laboratory information management systems.

Disclaimer

As part of our recruitment process, we may use digital or artificial intelligence-enabled tools to assist with tasks such as résumé screening, skills matching, or scheduling. These tools do not make final hiring decisions. All employment decisions are made by people.

We are committed to fair, inclusive, and bias-aware hiring practices and comply with Ontario legislation. If you require accommodation at any stage of the recruitment process, please let us know.