Quality Specialist

**Caring for Life. Make a difference. Be the difference.**

Calea is Canada’s leader in the provision of products and services that safely and reliably support community-based infusion therapy, advanced wound care, and the need for general medical supplies.

We are a community partner and licensed Pharmacy, providing expert solutions and support resources to healthcare professionals, hospitals, patients and their caregivers, and home care programs across the country. Calea supports patient care provided by several of Ontario’s largest Local Health Integration Networks’ (LHINs) Home and Community Care services. Our customers also include Regional Health Authorities.

Our people, experience, systems, and facilities make us a trusted partner in delivering innovative, cost-effective, patient-focused care that preserves independence and enhances quality of life. With over 280 employees and pharmacy locations in four provinces, Calea is committed to continually advancing the delivery of safe, high-quality community care.

If you are looking to work for a growing, global corporation that is focused on making meaningful improvements in the safety, affordability, and availability of the care medical professionals provide to their patients, then you should consider Calea & Fresenius Kabi Canada. We are an employer that works to build great leaders, teams and businesses. We know our employees are key to everything we accomplish, so we give them the freedom and resources to reach their potential and the opportunity to work with managers who care about their professional development.

**We are currently seeking a **full-time Quality Specialist** to join our team in Burnaby.**

**JOB DESCRIPTION**

Under the direction of the Senior Manager Quality, the Quality Specialist supports the compliance of the Compounding business unit to applicable corporate and regulatory requirements. The role ensures the Quality Management Systems (QMS) is maintained and continuously improved to maximize performance, business efficiency, customer service requirements, and patient safety.
- Participates in product and material complaints investigations, and resolutions.
- Creates and implement SOPs and participates in personnel training.
- Participates in self-inspections; verification of aseptic processing, product storage, transportation, and distribution conditions to minimize quality risk.
- Assists in the preparation and review of GMP documentation (test results, log books, batch records, SOPs, validation records, inspection requests, etc.) to ensure compliance.
- Maintains knowledge database of applicable Standards and Guidelines (FK, Compounding / Compliance, Patient Safety, Risk Management, ISO) via Documentum or similar software.
- Assists in the development and implementation of plans, teams and activities supervision, to ensure goals are achieved within time frames, measure effectiveness of changes,
- Assists in data trending and analysis and in the maintenance, improvement and communication of facility and quality KPIs. Maintain assigned KPI Database, and associated Records and Reports.
- Participates in continuous improvement initiatives, and/or revisions of workflow in an effort to reduce errors. Participates in and facilitate process improvement meetings, making recommendations, as applicable.
- Participates in special projects as requested by the Senior Manager Quality, for needed improvements.
- Focuses on the maintenance and improvement of Compounding’s Quality Management Program with the goal of maximizing patient safety, and customer satisfaction.

**QUALIFICATIONS**
- Diploma in Biological Technology with an emphasis on Industrial Microbiology or Aseptic Processing: i.e. Certification in industry-specific Post-secondary science
- based education covering the major requirements of the pharmaceutical industry.
- 5+ years years quality and compliance experience in the pharmaceutical industry and in particular clean room environment preferred
- Experience with Sterile Compounding environments, Aseptic Technique, and Validation
- Extensive knowledge in Microsoft Office tools, SAP, Quality Management System (QMS) software such as TrackWise, Documentum, etc.
- Working knowledge of Quality and Aseptic processing principles, NAPRA, USP
, Risk Management, Root Cause Analysis and continuous quality improvement Knowledge of GMP / ISO, particularly as they relate to quality control

**SKILLS**
- Excellent communication skills (written and verbal)
- Excellent customer service skills and the ability to collaborate with all levels both inside and outside the organization
- Microbiology background and aseptic processing experience
- Experience and/understanding with various QMS software
- ISO9001 Auditor Certification or Auditor training
- Strong computer skills in MS Office Excel database management/development
- Self-motivated and able to work with mínimal supervision
- Strong attention to detail with the ability to multi-task a