Bayshore HealthCare is hiring a Quality Specialist to support our commitment to excellence in healthcare. In this role, you will be instrumental in implementing and maintaining our Quality Management System (QMS), Document Management System (DMS), and Learning Management System (LMS). You will partner with business lines on quality events, risk management, and audit programs, while also collaborating closely with Supply Chain and Logistics to ensure regulatory compliance for pharmaceutical distribution.
What You'll Do
- Participate in the development, implementation, and maintenance of the Quality Management System and Document Management System.
- Ensure processes meet established quality standards and all applicable regulatory and legislative requirements, managing version control through the document change control process.
- Review and update policies, SOPs, and work instructions; contribute to developing new documents and evaluate their effectiveness.
- Ensure proper training assignments for newly implemented policies and procedures and communicate changes to all employees.
- Support the management of quality events (deviations), conducting root cause analysis and investigations, and ensuring CAPA plans are effective and close on time.
- Assist with quality event trend analysis and resulting improvement initiatives.
- Identify training needs, participate in developing training materials, and lead training to meet quality standards and contractual requirements.
- Educate internal stakeholders on key quality deliverables and identify process improvements to increase efficiency, effectiveness, and quality.
- Liaise with Quality leads from other business lines to collaborate on initiatives or adapt mutually beneficial processes.
- Collaborate with Supply Chain and Logistics teams to ensure compliance with Good Distribution Practices (GDP) and other regulatory requirements for pharmaceutical wholesale and distribution.
- Monitor and review supply chain processes, including procurement, storage, transportation, and delivery, to ensure adherence to quality standards and minimize risk.
- Support vendor qualification and management for suppliers, transportation providers, and third-party logistics partners to ensure compliance with quality and regulatory standards.
- Assist in managing temperature-controlled logistics and monitoring systems to maintain product integrity throughout the distribution process.
- Participate in investigations related to supply chain deviations, shipping discrepancies, and product returns, ensuring timely resolution and corrective actions.
- Work with inventory management teams to ensure accurate documentation, traceability, and reconciliation of pharmaceutical products.
What We're Looking For
- Bachelor’s degree, preferably in a health-related field.
- At least 3-5 years of experience in quality assurance, preferably in healthcare or life sciences.
- Experience in supply chain and logistics operations, preferably in pharmaceutical wholesale and distribution, including knowledge of Good Distribution Practices (GDP).
- Experience in developing policies, SOPs, and work instructions.
- Knowledge of inventory management, cold chain logistics, and vendor qualification processes.
- Experience in managing deviations, root cause analysis (RCA), and CAPA plans.
- Experience using quality systems like QMS, DMS, LMS, as well as ERP and CRM applications.
Nice to Have
- ASQ Quality certification, ISO Auditor Certification, or equivalent quality certification.
- Completion of Quality Management, Risk Management, or related courses.
- Understanding of QMS Validation.
- Previous experience working with Health Canada on medical device establishments.
Technical Stack
- QMS (Quality Management System)
- DMS (Document Management System)
- LMS (Learning Management System)
- ERP
- CRM
Team & Environment
This role reports to the Manager, Quality & Risk Management.
Work Mode
This position offers a hybrid work arrangement.
Bayshore HealthCare is an equal opportunity employer.
