QA Specialist - Deviation and CAPA
Top Benefits
About the role
Position Type: Full Time
Department: Quality Assurance
Work Location: Markham, ON
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 QA Specialist – Deviation and CAPA role is based in our facility in Markham and the key functions include supporting the Senior Manager, Quality Assurance and working with cross-functional teams to ensure the Quality Management System (QMS) is being followed. They will be leading the investigation and documentation into deviations and CAPAs related to GVP, GMP, CSV and contractual requirements. This role is also responsible for trending, metrics and training. Preparing and/or presenting on trending and metrics to senior leadership may also be required.
Occasional support for internal 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):
Investigation Management:
- Leading investigations into deviations related to GVP, GMP, GCP or CSV issues.
Risk Assessment and trending:
- Determining the impact of deviations (minor, major, or critical) on product quality and patient safety.
- Trending deviations in real time and periodically as part of continuous improvement to look for Opportunities.
- Measure metrics related to deviations and Capas on a routine basis, assign actions to address any negative trends in metrics.
- Present on deviations to senior leadership as requested.
Deviation and CAPA Implementation:
- Oversee the deviation process including ensuring timely initiation and deviations are being completed in compliance with Sentrex and client procedures.
- Developing and overseeing Corrective and Preventive Actions to prevent recurrence.
Documentation and Reporting:
- Ensuring all deviations are documented, reviewed, and approved by Quality Assurance (QA) in a timely manner.
- Approving deviations on behalf of QA.
Regulatory Compliance:
- Maintaining compliance with Health Canada and client contractual requirements to ensure we are always in an audit ready state.
- Cross-functional Collaboration:
- Working with PSP, PV, IT, WH, and quality teams to resolve issues.
Training and procedures:
- Ensure all deviation and CAPA procedures are compliant and current.
- Develop and deliver training to ensure users and QA team members are trained on the deviation and Capa process.
- Any other responsibilities as determined by the manager.
What you need to ensure you are set up for success:
- You have a Bachelor of Science degree in Chemistry, Biochemistry, Biology or other related discipline and a minimum of three (3) to five (5) years of knowledge and working experience in pharmaceutical quality assurance including a minimum of three (3) years leading deviation and CAPA investigations.
- 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 PSP – Patient Support Programs is an asset.
- Experience with ZenQMS or other QMS software is an asset.
- You have excellent English verbal and written communication skills.
- Bilingualism (French/English) is considered 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.
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
- The anticipated base salary hiring range for this role is $65K to $80K annually. The final base salary will be determined based on relevant experience, skills, and internal equity.
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.
Sentrex hiring managers may use artificial intelligence tools to assist them in the recruitment process.
#LI-RB1
Not the right fit? Search for QA Specialist jobs in Ontario, Canada
About Sentrex Health Solutions
Proudly Canadian, Sentrex is a patient support services provider, specialty pharmacy, and pharmaceutical distributor committed to simplifying access to care and improving patients’ lives. Founded in 2017 with a bold vision to challenge the industry’s status quo, we’ve grown rapidly—supporting over 60,000 PSP patients and 140,000 pharmacy patients across Canada in just five years. Today, our national presence includes 7 specialty pharmacy locations and a network of PerCuro by Sentrex specialty clinics, all dedicated to redefining care and exceeding expectations. Agile and responsive, we adapt quickly to meet our clients’ evolving needs, while empowering our people to make a meaningful impact every day.
Sentrex, une entreprise fièrement canadienne, est un fournisseur de services de soutien aux patients, une pharmacie spécialisée et un distributeur de produits pharmaceutiques, déterminée à simplifier l’accès aux soins et à améliorer la vie des patients. Fondée en 2017 avec une vision audacieuse pour remettre en question le statu quo de l’industrie, Sentrex a connu une croissance rapide, soutenant plus de 60 000 patients par l’intermédiaire de ses programmes de soutien et plus de 140 000 patients faisant appel à ses services pharmaceutiques partout au Canada en seulement cinq ans. Aujourd’hui, nous sommes présents à l’échelle nationale et possédons sept pharmacies spécialisées et un réseau de cliniques spécialisées PerCuro de Sentrex, qui visent toutes à redéfinir les soins et à dépasser les attentes. Agiles et réactifs, nous nous adaptons rapidement afin de répondre aux besoins changeants de nos clients, tout en donnant à nos employés les moyens de faire une réelle différence tous les jours.
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QA Specialist - Deviation and CAPA
Top Benefits
About the role
Position Type: Full Time
Department: Quality Assurance
Work Location: Markham, ON
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 QA Specialist – Deviation and CAPA role is based in our facility in Markham and the key functions include supporting the Senior Manager, Quality Assurance and working with cross-functional teams to ensure the Quality Management System (QMS) is being followed. They will be leading the investigation and documentation into deviations and CAPAs related to GVP, GMP, CSV and contractual requirements. This role is also responsible for trending, metrics and training. Preparing and/or presenting on trending and metrics to senior leadership may also be required.
Occasional support for internal 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):
Investigation Management:
- Leading investigations into deviations related to GVP, GMP, GCP or CSV issues.
Risk Assessment and trending:
- Determining the impact of deviations (minor, major, or critical) on product quality and patient safety.
- Trending deviations in real time and periodically as part of continuous improvement to look for Opportunities.
- Measure metrics related to deviations and Capas on a routine basis, assign actions to address any negative trends in metrics.
- Present on deviations to senior leadership as requested.
Deviation and CAPA Implementation:
- Oversee the deviation process including ensuring timely initiation and deviations are being completed in compliance with Sentrex and client procedures.
- Developing and overseeing Corrective and Preventive Actions to prevent recurrence.
Documentation and Reporting:
- Ensuring all deviations are documented, reviewed, and approved by Quality Assurance (QA) in a timely manner.
- Approving deviations on behalf of QA.
Regulatory Compliance:
- Maintaining compliance with Health Canada and client contractual requirements to ensure we are always in an audit ready state.
- Cross-functional Collaboration:
- Working with PSP, PV, IT, WH, and quality teams to resolve issues.
Training and procedures:
- Ensure all deviation and CAPA procedures are compliant and current.
- Develop and deliver training to ensure users and QA team members are trained on the deviation and Capa process.
- Any other responsibilities as determined by the manager.
What you need to ensure you are set up for success:
- You have a Bachelor of Science degree in Chemistry, Biochemistry, Biology or other related discipline and a minimum of three (3) to five (5) years of knowledge and working experience in pharmaceutical quality assurance including a minimum of three (3) years leading deviation and CAPA investigations.
- 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 PSP – Patient Support Programs is an asset.
- Experience with ZenQMS or other QMS software is an asset.
- You have excellent English verbal and written communication skills.
- Bilingualism (French/English) is considered 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.
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
- The anticipated base salary hiring range for this role is $65K to $80K annually. The final base salary will be determined based on relevant experience, skills, and internal equity.
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.
Sentrex hiring managers may use artificial intelligence tools to assist them in the recruitment process.
#LI-RB1
Not the right fit? Search for QA Specialist jobs in Ontario, Canada
About Sentrex Health Solutions
Proudly Canadian, Sentrex is a patient support services provider, specialty pharmacy, and pharmaceutical distributor committed to simplifying access to care and improving patients’ lives. Founded in 2017 with a bold vision to challenge the industry’s status quo, we’ve grown rapidly—supporting over 60,000 PSP patients and 140,000 pharmacy patients across Canada in just five years. Today, our national presence includes 7 specialty pharmacy locations and a network of PerCuro by Sentrex specialty clinics, all dedicated to redefining care and exceeding expectations. Agile and responsive, we adapt quickly to meet our clients’ evolving needs, while empowering our people to make a meaningful impact every day.
Sentrex, une entreprise fièrement canadienne, est un fournisseur de services de soutien aux patients, une pharmacie spécialisée et un distributeur de produits pharmaceutiques, déterminée à simplifier l’accès aux soins et à améliorer la vie des patients. Fondée en 2017 avec une vision audacieuse pour remettre en question le statu quo de l’industrie, Sentrex a connu une croissance rapide, soutenant plus de 60 000 patients par l’intermédiaire de ses programmes de soutien et plus de 140 000 patients faisant appel à ses services pharmaceutiques partout au Canada en seulement cinq ans. Aujourd’hui, nous sommes présents à l’échelle nationale et possédons sept pharmacies spécialisées et un réseau de cliniques spécialisées PerCuro de Sentrex, qui visent toutes à redéfinir les soins et à dépasser les attentes. Agiles et réactifs, nous nous adaptons rapidement afin de répondre aux besoins changeants de nos clients, tout en donnant à nos employés les moyens de faire une réelle différence tous les jours.