At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
Senior Quality Assurance Associate - Investigations
We are seeking a dedicated and detail-oriented Senior QA Associate – Investigations, to join our Bayer Inc Quality Assurance team. In this role, you will manage the entry, investigation, documentation, and follow-up of quality-related issues, including complaints, deviations, and CAPAs. You will play a crucial role in ensuring compliance with local, corporate, and regulatory standards while maintaining a high level of accuracy and efficiency. This position is specifically focused on 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:
Lead and conduct thorough investigations of complaints and deviations, developing and implementing corrective and preventive actions in alignment with local, global, and regulatory requirements.
Demonstrate exceptional attention to detail and accuracy while independently organizing and prioritizing tasks in a dynamic environment.
Ensure efficient information flow between internal stakeholders, including Medical Information, Pharmacovigilance, Customer Service, and the Global Business Services team in Costa Rica.
Identify and escalate potential high-risk issues, deviations, and complaints as necessary.
Conduct comprehensive analysis of deviation and complaint data, supporting the creation of complaint trend reports and quality metrics to enhance quality systems.
Review and approve investigations conducted by suppliers and CMOs, ensuring compliance with Bayer requirements.
Prepare and deliver clear, professional written communications to customers regarding the outcomes of complaint investigations.
Perform immediate actions to mitigate risk, including product holds and distribution reports.
Collect data for KPIs to evaluate system performance and identify opportunities for improvement.
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 2 years of experience in Quality Assurance or Quality Control within the pharmaceutical or biotechnology industry, with at least 2 years in investigations and CAPA management.
Strong understanding of Health Canada regulatory requirements and Good Manufacturing Practices (GMP).
Excellent technical writing skills with a focus on accuracy, clarity, conciseness, readability, and correctness.
Proven problem-solving and critical thinking abilities, particularly in root cause analysis and risk mitigation.
Ability to perform risk assessments and make informed decisions.
Fast learner, action-oriented, and agile in approach.
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:
842810
