Product Release Specialist

at  Calea Ltd

ADVANCING PATIENT CARE.

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 Product Release Specialist to join our Quality Department, at our corporate office in Toronto (165 Galaxy Blvd.)
The Product Release Specialist manages the completion of the quality inspection of all drug and device products released into the market by ensuring the product meets the market authorization, and is safe and effective for administering to patients.

QUALIFICATIONS

• Minimum Bachelor of Science degree in chemistry and/or microbiology
• Minimum five years QC laboratory experience or equivalent required
• Sound knowledge of GMP and GLP along with testing technology in chemistry and microbiology required
• Previous experience analyzing laboratory results
• Excellent analytical skills with attention to detail and a high level of accuracy
• Excellent communication skills both oral and written
• Results oriented
• Ability to work in a team environment as well as work independently with minimum supervision
• Professional demeanor
• Ability to multitask, prioritize and problem solve efficiently
• Experience in word processing and spreadsheets required
• Experience with sterile injectables is an asset
• Working experience in SAP is an asset

• Organizing the batch review priorities to ensure batches are reviewed to prevent delays in product releases
• Coordinating the sampling of the incoming finished products for the third party testing lab
• Requesting and review of batch documentation from the fabricators
• Evaluating transportation and storage conditions of the products to ensure compliance with Health Canada GUI-0069 requirements
• Reviewing third party laboratory results and raw data for compliance to release specifications
• Releasing product for sale
• Initiate deviation reporting when necessary
• Perform KPI trending of product release related activities
• Maintain close liaison within QA/QC and with SC Depts. to ensure that product release priorities are met in a timely manner