Senior Quality Assurance Specialist

Position Type: Full Time

Department: Quality Assurance

Work Location: Markham

Work Arrangement: Hybrid

Work Hours: Monday to Friday - standard business hours

Travel Required: No

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. We do this through strategic distribution models and patient support programs that are backed by powerful, integrated technology, a dedicated in-house creative agency, and experienced, cross-functional teams. 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 Senior QA Specialist role is based in our facility in Markham and the key functions include supporting the Manager, Quality Assurance and working with cross-functional teams to ensure the Quality Management System (QMS) is being followed. They will be working on document control, deviations, CAPAs, complaints & computer validation. Occasional support for internal and external audits is required They will also be an ambassador for the quality culture in Sentrex.

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

• Ensure compliance to all applicable regulatory requirements and the Sentrex Health Solutions QMS.
• Assist in creating a continued quality culture in the workplace by ensuring that all employees understand the importance of quality concepts.
• Responsible for the development and review of quality documents.
• Responsible for the development and maintenance of the SOPs, WIs, forms and change controls and to assist the manager with their approval.
• Create and conduct training presentations for quality assurance regulations and guidelines e.g., GMP, GVP, GAMP V, deviations, CAPAs or equivalent.
• Support the QMS with regards to change controls, deviations, CAPAs, complaints, validation, and continuous improvement.
• Review of deviation reports to ensure they are addressed at the site level, including root cause(s), completeness, appropriate and meaningful CAPAs, and their timely implementation.
• Assist the manager with training of new quality personnel with regards to deviations and CAPAs.
• Assist the manager with approving deviations, CAPAs and changes.
• Helping to build out the Computer System Validation (CSV) program at Sentrex.
• Assisting the Manager to execute and approve computer validations.
• Support the Manager and Auditors as required with the internal and external audit program.
• Other duties as assigned by you manager
  
  
  

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

• BSc. in a relevant field such as biology, chemistry, biochemistry, pharmacy, etc.
• 5-7 years of experience in the pharmaceutical environment with a strong focus on deviations and CAPAs.
• Completion of a post graduate diploma in Quality Assurance or Regulatory Affairs.
• Good understanding of Health Canada GxP regulations.
• Proficient in the Microsoft Suite of products. Able to work on various databases.
• Exceptional organizational skills and strong attention to detail.
• Demonstrated prioritization skills and ability to multi-task to meet tight deadlines.
• Proven analytical and problem-solving skills.
• Above average verbal and written English communication skills.
• Ability to work as part of a team and have a collaborative mindset to work with cross-functional partners.
• Bilingualism (French English) is preferred.
  
  
  

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.
  
  
  

Why join Sentrex?

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.