Supplier Quality Assurance Auditor (Markham, Hybrid)

Sentrex Health Solutions Inc.; Markham; Hybrid; CAD 60,000 - 100,000; Full time

Job summary

Join a forward-thinking company as a Supplier Quality Assurance Auditor in Markham! In this pivotal role, you will ensure compliance with quality management systems while conducting audits and collaborating with cross-functional teams. Your expertise will help enhance patient care, making a significant impact on the healthcare industry. With a hybrid work environment and a culture that values diversity and inclusion, this role offers a unique opportunity to grow professionally while contributing to a high-performing team. If you are detail-oriented and passionate about quality assurance, this is the perfect opportunity for you!

Benefits

Competitive Salary

Generous Vacation Entitlement

Wellness Program

Paid Sick Days

Dental & Extended Health Benefits

RRSP Matching Program

Employee & Family Assistance Program

Qualifications

• 3-5 years experience in quality assurance in a pharmaceutical organization.
• Thorough knowledge of Canadian Food and Drug Regulations.

Responsibilities

• Conduct and document external audits of infusion clinics.
• Analyze audit data and provide recommendations for patient care.

Skills

Quality Assurance

Regulatory Compliance

Auditing

Communication Skills

Detail-oriented

Bilingualism (French/English)

Education

Bachelor’s degree in Chemistry, Biochemistry, Biology

Tools

Auditing Software

GMP

GVP

GCP

ICH Regulations

Job description

Supplier Quality Assurance Auditor (Markham, Hybrid)

Job Category: Quality and Pharmacovigilance

Requisition Number: SUPPL002252

Posted: April 11, 2025

Job Type: Full-Time

Work Location: Markham

Work Arrangement: Hybrid

Work Hours: Monday to Friday - standard business hours

Travel Required: Yes (Occasionally across Canada)

A proudly Canadian company, Sentrex Health Solutions is a fully integrated specialty distributor and patient support provider for pharmaceutical manufacturers, physicians, and their patients. We provide innovative solutions focused on ensuring patients have access and the support they need to maximize their treatment outcomes. Our core capabilities include Specialty Pharmacy Services, Customized Solutions for Warehouse, Wholesale & Distribution, Patient Support Programs, Strategic Creative Services as well as HCP & Clinic Services.

Come and join our team! But first, let us tell you why we love working here:

• We are 100% Canadian with locations across the country
• State-of-the-art facilities to provide high-quality products and services
• The opportunity to be a part of a winning, high-performing team
• Collaborative, engaging workplace culture – we are passionate about our people!
• Flexible working environment that promotes a healthy work-life balance
• Diverse and inclusive culture where your talent and commitment to excellence is welcomed and valued
• High-growth environment that provides opportunities for learning and growth supported by our Employee Development Program and industry-leading, in-house corporate training offered throughout the year

The Opportunity:

The Supplier QA Auditor role is based in our facility in Markham and the key functions include working with cross-functional teams to ensure the Quality Management System (QMS) is being followed and supported by our vendors.

In this role you will be required to schedule, conduct and document assigned external audits (i.e. Infusion partners & wholesale related third parties), as well as participating in regulatory inspections with approved procedures and schedules. You will analyze audit data (i.e. from infusion clinic audits) and provide recommendations to improve the quality and safety of patient care. You will also be an ambassador for the quality culture in Sentrex.

A Day in the Life (What you will do here):

The Supplier QA Auditor, reporting to an independent Quality Assurance team at Sentrex will contribute to the team’s success by:

Infusion Clinic Quality Audit & Monitoring:

• Perform regular quality audits of infusion clinics, and work closely with the infusion experience managers to improve the safety of patient care.
• Review clinic processes, patient records, and infusion therapy protocols to ensure compliance to applicable regulations and client requirements.
• Document audit findings in the validated Quality Management System, and follow-up on corrective & preventive actions.
• On a periodic basis, monitor the quality of the performance of the infusion clinics, ensuring a standardization of processes across infusion partners.
• Complete a monthly quality metric analysis to report performance of infusions and highlight any risk or opportunities.
• Investigate any patient safety complaints, in collaboration with the QA Manager and VP, Quality & Patient Safety.
• Collaborate with the pharmacovigilance department to ensure that all PV training (Sentrex & Client) are completed and adverse event reporting processes are well defined and adhered to.
• Maintain an approved infusion supplier & wholesale third-party list.

Other:

• Support wholesale related supplier audits, to ensure the compliance of our vendors to applicable drug and medical devices regulations.
• Complete Audit schedules and execute audits per plan.
• Travel, as required, nationally within Canada.
• Write SOPs, and stay current with all applicable regulations.
• Write audit plans, audit reports, audit close-out letters in accordance with the Quality Assurance department's approved timelines and templates.
• Additional duties as determined by your Manager.

What you need to ensure you are set up for success:

• You have a Bachelor’s degree in Chemistry, Biochemistry, Biology or other related discipline and a minimum of three (3) to five (5) years of knowledge and working experience with all aspects of quality assurance which relate to a pharmaceutical organization.
• You are well organized and detail-oriented.
• You have a thorough knowledge and understanding of Canadian (Health Canada) Food and Drug Regulations and guidelines.
• You have experience with GMP, GVP, GCP, ICH regulations and guidelines.
• Experience with auditing software vendors and/or GAMP V / CSV is an asset.
• You have excellent verbal and written communication skills.
• Bilingualism (French/English) is considered an asset.
• Experience participating in regulatory agency inspections is an asset.
• Certification in a recognized quality auditor program is an asset.

What makes you a great fit for this team:

• Your commitment to providing a high level of service to your internal and external clients.
• You are highly adaptable with a track record of success during times of growth and organizational change.
• You have a proven track record of developing trust and influence at multiple levels.
• You demonstrate an impactful and candid communication style.
• You have exceptional organizational skills with the ability to build effective working relationships with colleagues, management, and stakeholders.

We value our employees! Our permanent full-time employees are provided with a:

• Competitive Salary and generous vacation entitlement
• Wellness Program (5 paid days off for your well-being!)
• Paid Sick Days
• Competitive Benefits Package including Dental & Extended Health Benefits, AD&D, LTD & Employee/Dependent Life Insurance
• Employee & Family Assistance Program
• RRSP Matching Program

Sentrex Health Solutions is proud to be an equal opportunity employer demonstrated by our commitment to diversity, inclusion, belonging, equity, and accessibility. We provide a safe space for all team members to express their individuality within our corporate culture.

We encourage you to apply and accept all applications. We realize that not every candidate will meet every single desired qualification. If your experience looks a little different from what we have identified and you think you can bring value to the role, we would love to learn more about you!

Accommodations can be made available upon request for those candidates taking part in the selection process.