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Quality Assurance Specialist
2 weeks ago
**Position Type**: Full Time
**Department**:QA
**Work Location**: Markham, ON
**Work Arrangement**: 90% Remote, 10% on site
**Work Hours**:Standard Business Hours Monday to Friday
**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 and experienced, cross-functional teams. Our core capabilities include **Specialty Pharmacy Services, Customized Solutions for Warehouse, Wholesale & Distribution, Patient Support Programs, 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
- Quarterly virtual social events
**The Opportunity**:
The QA Specialist 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. They will be working on document control, training, deviations, CAPAs, & audits (both internal and external). They will also be an ambassador for the quality culture in Sentrex.
**A Day in the Life (What you will do here)**:
- Ensure compliance with 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 all relevant quality concepts.
- Conduct audits of operations (internal and vendor) and ensure work is conducted in accordance with applicable Standard Operating Procedure(s) and work instructions.
- Responsible for the development and review of quality documents.
- Responsible for the development and maintenance of the SOPs, WI, forms and change controls.
- Review and sign off on QA records such as certificates of destruction, calibration records, sanitation, pest control, training, etc.
- Monitor temperature conditions of the facilities as well as review inbound product temperature conditions.
- Create and conduct training presentations for Quality Assurance regulations and guidelines e.g., GMP, GVP, GAMP V or equivalent.
- Maintain site documentation control and records retention for all local forms, working instructions, profiles, customer SOP's, and client specific documentation.
- Support the QMS with regards to document control, Change control, deviations/CAPAs, training etc.
- Review and reporting of deviations to ensure they are addressed at site level, including root causes completeness and timely implementation of CAPAs.
- Helping to build out the Computer System Validation (CSV) program at Sentrex.
- Additional duties as assigned by the Manager.
**What you need to ensure you are set up for success**:
- BSc or 3-5 years of Quality Assurance experience.
- Good understanding of Health Canada GxP regulations.
- Proficient in the Microsoft Suite of products. Able to work in 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 communication skills.
- Ability to work as part of a team and have a collaborative mind-set to work with cross-functional partners.
- Previous experience working with a PSP program is preferred.
- Working knowledge of French 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.
**Why join Sentrex?**
We value our employees Our permanent full-time employees are provided with a:
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