Quality Assurance Specialist

Fresenius Medical Care•Richmond Hill, ON

5d•CA$65,000 - CA$75,000•Onsite

About The Position

Under the direction of the Head of Quality, this individual will be responsible for completing quality assurance aspects of the day-to-day operations within Fresenius Medical Care Canada (FME Canada), assuring that all operations are conducted in compliance with Canadian Regulations. This role supports FME Canada’s mission, vision, core values and customer service philosophy, and adheres to the FME Canada Compliance Program, including following all regulatory and division/company policy requirements.

Requirements

1-3 years of experience in a quality assurance role at a pharmaceutical or device company
Understanding of medical device and GMP regulations is essential.
Highly developed written and oral communication skills essential in English and preferably in French as well.
Ability to effectively organize projects.
Strong commitment to accuracy and detail is critical.

Nice To Haves

Post graduate QARA certification is preferred.

Responsibilities

Initiate Change Controls, review and prepare Standard Operating Procedures (SOPs) relating to quality assurance activities at FME Canada.
Review of incoming lot shipment documentation, temperature data and testing results and to manage release of imported drug products to the Canadian market.
Review and maintain batch documentation, CofAs and CofMs, confirmatory testing, stability data for imported drug products, and interact with appropriate manufacturers to obtain required documentation as per GMPs requirements.
Co-ordinate and follow up with manufacturers for preparation of Annual Product Summary Reports for drugs and devices, review and file these documents locally.
Manage quality activities regarding product returns and document associated disposition decisions.
Manage quality activities regarding product destruction.
Monitor corporate hold notifications and internal quality hold requests and manage the quarantine and disposition of impacted product.
Conduct sampling and inspection activities as need and disposition products in the ERP system.
Manage document retention for all quality assurance documents and archive according to established procedures.
On occasion, preparation of class 2 device applications or other regulatory tasks may be required.
Responsible for driving the FME Canada culture through values and customer service standards.
Accountable for outstanding customer service to all external and internal customers.
Develops and maintains effective relationships through effective and timely communication.
Takes initiative and action to respond, resolve and follow up regarding customer service issues with all customers in a timely manner.
Other duties as assigned.