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QA Compliance Associate (17 Months Job Rotation)

Hybrid
Burlington, Ontario
CA$75,000 - CA$100,000/annual
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Top Benefits

Generous paid time off (vacation, personal days)
Comprehensive flexible benefits
Defined Contribution Pension Plan with RRSP match

About the role

The Position Ready to make an impact? Boehringer Ingelheim is looking for a dynamic, detail-driven Quality Compliance Associate (QCA) supporting Animal Health business to join our Commercial Quality Assurance team who’s passionate about quality and excited to help deliver high-quality products to Canadian patients and customers.

The Quality Compliance Associate (QCA) role is part of the Quality Management System (QMS) in Boehringer Ingelheim Quality and has an important role in supporting and maintaining the quality and compliance at Business Operating Unit (BOPU) Canada by ensuring all internal and external health authority and corporate requirements are implemented, monitored, adhered to and improved when required.

The QCA will actively contribute and support the establishment, maintenance,compliance and continuous improvement of the BOPU Canada QMS with all relevant health authority, corporate, Good Manufacturing Practice (GMP) and Good Distribution and Storage Practices (GDSP) requirements.

The QCA contributions in the implementation, maintenance and continuous improvement of the QMS, processes related to the commercial product supply at BOPU Canada is a key success factor for delivering consistent quality product to Canadian customers.

This job posting is for an existing vacant position.

Responsibilities AUDITING/ INSPECTIONS:

Actively participate and support health authority inspections, internal audits, self-inspections, and external service providers/suppliers audits including CAPA response plans/CAPAs resulting from audit findings under the direction of the HoCQA and/or SQCA.

Support quality issues with potential for market actions and market recall activities as required.

Contribute to review of QAAs.

Actively contribute to continuous quality and compliance optimization opportunities within BOPU Canada.

Promptly escalate quality issues to senior QA team.

TECHNICAL PRODUCT COMPLAINTS:

Initiate TPCs in Trackwise including follow-up with complainant when required to obtain additional information.

Enter complaint sample information in Trackwise and coordinate shipment of complaint samples to investigating site when required.

Act as a back-up to senior QA team to close out TPCs in Trackwise when required.

BATCH DISPOSITIONS:

Ensure batch dispositions are made in compliance with regulatory marketing authorization, health authority and corporate requirements for marketed products in Canada.

As part of the batch dispositon process, manage the associated activities of creating, maintaining, filing, reviewing and assessing technical documents (batch documentation, master documents, change controls, deviations, investigations, CAPAs, unique identifier, retains and sample testing) including coordinating communications and QA activities with 3PL.

Ensure timely review, approval and release of products for distribution as per health authority regulatory requirements.

SAP user for QM transactions

Support product launch activities including local repackaging activities.

Manage reference standards for sample testing.

Support SQCA in analytical method transfers with contract laboratories.

COMPLIANCE ACTIVITIES:

Plan and manage for timely review of annual confirmatory testing, associated test results/ data and executed batch record reviews for product portfolio.

Assist senior QA team in preparation and review of product quality and stability reviews when required.

Assist senior QA team in preparation and review of trending reports for TPCs, events and deviations.

Escalate quality issues to senior QA team promptly.

QUALITY OPERATIONAL ACTIVITIES:

Support senior QA team in performing periodic SOP reviews including reviewing/commenting on new or existing local procedures and initiating new SOP development when required.

Participate in reviewing draft /updated health authority and global guidances, regulations and procedures.

Manage controlled documents using eDMS.

This position is based in the Burlington, Ontario office located at 5180 South Service Road and is flexible. Employees in flexible roles are required to be at the office a minimum of 50% of the time each month and must report to the office when requested and required by their Manager/Department

Requirements

  • Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or related scientific field.
  • Demonstrated knowledge and hands on experience with GMP, Quality Control, and GDSP in the pharmaceutical industry.
  • Excellent attention to detail, organizational skills, and analytical thinking.
  • Strong written and verbal communication skills.
  • Ability to collaborate cross-functionally and work independently.
  • Sound judgment when balancing compliance and business needs.
  • Proficiency in Microsoft Office, SharePoint, Adobe Acrobat.
  • Experience in TrackWise and SAP (an asset).
  • Special projects as assigned.
  • Ability to travel occasionally for business needs.

Total Rewards We offer competitive total rewards that includes a generous amount of paid time off (vacation, personal days, contingency paid time off days for Long Term Contract Employees), comprehensive and flexible benefits plan, Defined Contribution Pension Plan with company matching of RRSPs, Employee and Family Assistance Plan, employee and leadership development programs, and programs to support overall health and wellness for employees.

Our total rewards philosophy reflects and recognizes employee contributions to the company.

Visit https://www.boehringer-ingelheim.com/ca/careers/explore-our-company/benefits-rewards

The salary range for this position is from $75,000 - 100,000. Performance, relevant experience and competency in the role will be a key factor in driving the compensation offered. In addition, this position is eligible for a variable bonus target opportunity of 10% of the annual base salary.

READY TO APPLY? Click the "Apply Now" button below to submit your application.

We thank all applicants for their interest in our company. Please note that only candidates selected for an interview will be contacted.

Boehringer Ingelheim Canada is committed to providing accommodations for people with disabilities to support their participation in all aspects of the recruitment and selection process. If you require accommodation, we will work with you to meet your needs.

Boehringer Ingelheim Canada does not use artificial intelligence to screen, assess, or select applicants in the recruitment process.

DEADLINE FOR APPLICATIONS Applications for this position will be accepted until February 19, 2026

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Our Company

Why Boehringer Ingelheim? With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com

About Boehringer Ingelheim

Pharmaceutical Manufacturing
10,000+

Our people are our strength. And, together with over 53,000 colleagues, we're creating the next breakthrough in the world of health and innovation for both humans and animals. Are you ready to join us? #LifeForward

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