Sr. Qa Associate - Investigations

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.

Sr. QA Associate - Investigations

A member of the deviations and product quality complaints investigation team at Bayer Inc. Performs quality investigations and problem solving in accordance with Good Manufacturing Practices (GMPs), quality systems, manufacturing controls and corporate regulations. As assigned, provides support in various related compliance and project functions.

Bayer is committed to a flexible hybrid working environment. This is a 12-month contract position based out of Mississauga, Ontario.

What you will do:

Responsible for the entry, investigation, documentation, and follow-up of quality related investigations including complaints and deviations, ensuring compliance with local, corporate and regulatory requirements. This includes, but is not limited to, the following:

• Review supplier investigations and deviation investigations including the associated corrective and preventive actions against Health Canada requirements.
• Perform analysis of complaint data for routine and spontaneous requests. Analyze and evaluate complaint data to ensure that timely and comprehensive complaint trend reports and quality metrics is created on a periodic basis.
• Responsible to ensure accurate and efficient information flow between internal stakeholders: Medical Information, Pharmacovigilance, Customer Service and Global Business Services team in Costa Rica.
• Detailed oriented with attention to accuracy, ability to independently organize and prioritize tasks in a dynamic environment including the ability to manage multiple investigations.
• Perform complaint investigations and deviation investigations including the associated corrective and preventive actions to ensure compliance with local, global and regulatory requirements.
• Responsible to provide written communication to customers on the outcome of the complaint investigations.
• Escalate critical complaints to Manager, QA Investigations/ Head of Quality relating to complaint trends and/or post market performance of Bayer’s products.

Who you are:

• Risk and conflict management experience
• Knowledge of GMP, ISO, Medical Devices, Auditing Techniques, Project Management, Pharmaceutical Industry, Quality Assurance
• University Degree in Science (e.g. Analytical Chemistry, Biochemistry, Microbiology) or related field
• Strong project management skills
• At least 3 years’ experience in the pharmaceutical industry, in a QA or QC role
• Strong organizational and communication skills
• Computer skills and efficiency with MS Office

This position requires full vaccination against COVID-19.

What we offer:

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

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.

Learn more about our values and purpose at: https://www.bayer.com/en/ca/canada-our-purpose-values

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.

Application Deadline: May 19, 2023

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:

791832