Quality Assurance Specialist Investigations

Job Responsibility:

QA Specialist - Investigations

We are looking for a skilled QA Specialist - Investigations to join our Quality Assurance team. In this role, you will oversee the complaint management and deviation processes, ensuring compliance with local, corporate, and regulatory requirements. You will manage the full lifecycle of product technical complaints (PTCs) and Usability Issues (UIs), drive procedural excellence, and foster cross-functional collaboration. This position is dedicated to Canadian requirements within the Quality Assurance organization.

Bayer is committed to a flexible hybrid working environment. This is a permanent position based out of Mississauga, ON.

What you will do:

• Ensure prompt assessment, entry, thorough investigation, and closure of all product technical complaints (PTCs) and Usability Issues (UIs) received by Bayer Canada, in compliance with Canadian regulatory requirements.
• Conduct comprehensive investigations into complaints and deviations, identifying and analyzing root causes, and driving the development and implementation of corrective and preventive actions.
• Collaborate with Contract Manufacturing Organizations (CMOs), supply centers, and quality teams to ensure alignment of root cause analysis and corrective actions with Health Canada standards.
• Review and approve PTC investigations and deviation investigations as assigned, ensuring compliance with Health Canada and global requirements.
• Oversee Canadian PTC activities performed by Global Business Services (GBS) in Costa Rica, ensuring adherence to Canadian requirements.
• Independently organize and prioritize tasks in a dynamic environment, managing multiple investigations concurrently while maintaining high-quality standards.
• Facilitate accurate and efficient information flow between internal stakeholders, including Medical Information, Pharmacovigilance, and Customer Service, ensuring effective communication and collaboration.
• Analyze complaint data to identify trends and assess the post-market performance of Bayer's products, generating timely complaint trend reports and quality metrics.
• Support the local Product Quality and Safety Committee (PQSC) with details of quality investigations to aid in risk assessments and mitigation actions.
• Ensure timely review and implementation of assigned global procedures and Health Canada regulations within your community.
• Provide support to team members and promote cross-functional collaboration to achieve shared objectives.
• Collect and analyze data for KPIs to evaluate system performance, providing insights to drive improvements and efficiencies.
• Develop, implement, and maintain Canadian procedures, ensuring alignment with corporate and regulatory standards.
• Prepare for audits and inspections, defining and overseeing the implementation of appropriate corrective and preventive actions (CAPAs) based on audit findings.
• Participate actively to foster a culture of inclusion, continuous improvement, and accountability.

Who you are:

• University Degree or College Diploma in Science (e.g., Chemistry, Biochemistry, Microbiology)
• Minimum of 5 of experience in Quality Assurance or Quality Control within the pharmaceutical or biotechnology industry, with at least 3 years in investigations and CAPA management.
• Experience in a GMP manufacturing environment is an asset.
• Strong understanding of Health Canada regulatory requirements and Good Manufacturing Practices (GMP).
• Excellent technical writing capabilities and knowledge of data integrity.
• Experience in performing quality investigations and problem-solving in accordance with Good Manufacturing Practices (GMPs).
• Outstanding problem-solving and critical thinking skills, focusing on root cause analysis and risk mitigation.
• Proven experience investigating major and critical deviations and complaints in a pharmaceutical environment.

What we offer:

• Competitive compensation and rewards package
• Collaborative, diverse and inclusive culture
• Career development and global opportunities
• Work-life flexibility programs such as flex hours, employee discounts, volunteer days, wellness, and other employee offerings

Bayer is committed to fostering, cultivating and preserving a culture of Inclusion and Diversity. We embrace and encourage our employees' differences and believe that our people are our most valuable asset. The collective sum of individual life experiences, knowledge, innovation, self-expression, unique capabilities that our employees invest in their work represents our culture, reputation, and Bayer's values and purpose.

All referral candidates must first be submitted via our internal referral system by a current Bayer employee in order to participate in the referral program. Once a Bayer employee has successfully referred you in our system, you will receive an automated email with instructions on how to complete your application.

This posting will be available for application until at least June 16, 2025.

#LI-CA

Bayer welcomes and encourages applications from people with disabilities. Candidates participating in our selection process requiring accommodation due to a disability or medical need are encouraged to notify the Bayer representative that they will be meeting with to ensure appropriate arrangements can be made.

Location:

Canada : Ontario : Mississauga

Division:

Pharmaceuticals

Reference Code:

842809