Quality Assurance Specialist

PURPOSE AND SCOPE:

Supports FME Canada’s mission, vision, core values and customer service philosophy.  Adheres to the FME Canada Compliance Program, including following all regulatory and division/company policy requirements.

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.

DUTIES / ACTIVITIES:

CUSTOMER SERVICE:

• 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.

PRINCIPAL RESPONSIBILITIES AND DUTIES:

• 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.

• Other duties as assigned.

​PHYSICAL DEMANDS AND WORKING CONDITIONS:

Typical office work environment with occasional lifting (documents or samples) less than 10kg. 

EDUCATION:

• B.Sc. in Biology, Chemistry or a health-related discipline.

• Post graduate QARA certification is preferred.

• 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.

SALARY: $65,000 - $75,000

Internal Contacts: Logistics, Customer Service, Warehouse and QARA Teammates.

External Contacts: Fresenius regulatory affairs, quality and manufacturing colleagues in the USA, Mexico and Europe.

SUPERVISION:

N/A

The duties listed in this job description are intended only as illustrations of the various types of work that may be performed.  The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. We are committed to providing a barrier-free environment for all stakeholders including our clients/customers, employees, job applicants, suppliers, and any visitors who may enter our premises, access our information, or use our services. As an organization, we respect and uphold the requirements set forth under the Accessibility for Ontarians with Disabilities Act (2005), and its associated standards and regulations.