QA Specialist - Deviation and CAPA

Description 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 Qualifications Skills Behaviors : Motivations : Education Experience Licenses & Certifications Sentrex Careers