Quality Support Associate

As a global healthcare company, Fresenius Kabi is Committed to Life. The company's products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With more than 41,000 employees and presence in over 100 countries, Fresenius Kabi's expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.

WHAT WE OFFER!

At Fresenius Kabi Canada we foster a collaborative environment where employees are encouraged to share ideas and contribute to meaningful work. We offer unique learning opportunities to grow and build your career. In addition, we value each and every contributor and offer various benefits and rewards (as applicable) including:

• Company paid health and dental benefits that start on your first day of employment
• Company matched RRSP program
• Generous vacation plan with one extra day accrual for each year of service
• Paid float days and paid sick days
• Employee assistance program
• Casual office dress code
• Employee recognition program
• Perkopolis & Goodlife Discounts
• Professional growth and development opportunities

We are currently seeking a Quality Support Associate to join our team!

On-site requirement 5 days/week

Location: 2400 Skymark Avenue, Unit 4, Mississauga, ON, L4W 5K5

The pay range for this role is: $60,000 - $85,000.

Placement within the range will be determined based on relevant skills, experience, qualifications, and internal equity. The final offer will reflect the successful candidate's background and demonstrated capabilities.

This position is an existing vacancy within the organization.

MAIN RESPONSIBILITIES

• Adheres to corporate, regulatory, and individual responsibilities supporting the Company's quality management programs, supporting policies, procedures, work instructions, and relevant software (eDMS, KabiTrack, gCMW, FLC)
• Creates, reviews, coordinates and tracks to ensure timely completion of controlled documents including SOP, WI, Policy, Manual, Form, Annex, MBRs, Assessment, Training Material, Job description, Risk Assessment, Supplier Qualification documents, Validation Protocol, etc.
• Edits and standardizes documents for clarity, conciseness, completeness, accuracy, formatting, grammar and terminology to meet company processes and standards.
• Works with stakeholders to prioritize controlled document updates to meet global and local standards and target completion dates.
• Routes documents for review and approval as per local SOP in electronic document management system (eDMS).
• Initiates periodic review of documents as defined in SOP.
• Implements the approved documents in timely manner as defined in SOP including Master Batch Records and issues controlled copies of documents as defined in SOP.
• Initiates the Document Training forms for new controlled documents.
• Assigns newly implemented documents for training and archives superseded documents in Learning management system (LMS).
• Assigns training to new hires in learning management system.
• Maintains and controls document control logs for document KPI, training assignment, user groups, user training KPI, logbooks, offsite storage, and global document gap assessment.
• Issues logbooks to Production and Quality departments, reconciles and files returned logbooks.
• Performs offsite and onsite documentation storage as defined in SOP.
• Support deviation, investigation, CAPA and change control processes including initiation support, documentation review, tracking of corrective and preventive actions, and verification of effectiveness in compliance with internal procedures.
• Support the Complaints management process including intake, documentation, tracking, investigation coordination and closure in accordance with internal procedures.
• Support Supplier qualification including coordination of supplier onboarding, review and maintenance of Quality agreements, verification of compliance documentation, and support for supplier performance monitoring in accordance with internal procedure.
• Participate in routine Quality presence in controlled areas to monitor adherence to approved procedures and aseptic practices.
• Support the environmental monitoring program through plate reading, documentation and consistent data tracking to ensure compliance, identify trends, and maintain a controlled and safe operational environment.
• Participate in internal audits and regulatory inspection preparation.
• Assist with trending and reporting of quality metrics/KPIs.
• Support implementation and continuous improvement of the Quality Management System.

QUALIFICATIONS

• University degree in science or a related college diploma in Pharmacy, Biotechnology, Microbiology, Quality Assurance or a related discipline with a minimum 3-5 years of work-related experience
• Experience in regulated industry (compounding, pharmaceutical) is an asset
• Experience with document control systems and quality records management
• Experience with an electronic document management system is an asset

SKILLS

• Excellent communication skills (written and verbal) with high attention to proper grammatical rules and guidelines
• Self-motivated and able to work with minimal supervision
• Strong attention to detail with the ability to multi-task and handle fluctuating workloads
• Excellent organizational, problem-solving, time-management and continuous improvement skills
• Proven ability to adhere to standards & procedures and maintain confidentiality
• Excellent customer service skills and the ability to collaborate with all levels both inside and outside the organization
• Strong computer skills in Microsoft® Office. Advanced level skills in word, Excel, Power point, Outlook, Adobe Acrobat, learning management system and electronic document management system are required.
• Strong business acumen with good judgement
• Above average skills in critical thinking, decision making, writing, finding information, document organization and effective use of memory
• Must be able to work consistently at a fast pace and maintain a regular processing volume that supports document control processing goals
• Excellent follow-up and project management skills
• Excellent analytical skills and high level of accuracy

MORE ABOUT US!

As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale.

In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients' nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is the global leader in supplying blood collection bags and devices, supporting blood banks and healthcare facilities worldwide. The company's I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care.

Fresenius Kabi takes a holistic approach to healthcare and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of almost 450 million patients annually.

Inclusion and Equal Opportunity Employment

At Fresenius Kabi Canada, we embrace diversity and inclusion for innovation and growth. We are committed to building inclusive teams and an equitable workplace for our employees to bring their true selves to work. We are taking actions to tackle issues of inequity and systemic bias to support our diverse talent, clients and communities. We are an equal opportunity employer.

In accordance with the Accessibility for Ontarians with Disabilities Act, 2005 and the Ontario Human Rights Code, we are committed to providing accommodations and will work with candidates to meet their needs and provide an accessible candidate experience. If you are a person with a disability and require assistance during the application process, please let us know ([email protected]). We welcome members of all backgrounds, experiences and perspectives to apply.

Artificial Intelligence (AI) Use in Recruitment:
Fresenius Kabi uses AI-supported tools to help compare applicant résumés with job requirements and identify potential matches. These tools do not make hiring decisions. All candidate reviews, selections, and decisions are made by our recruitment team.