Quality Support Associate

Build your Future with Fresenius Kabi Can ada
We are Committed to Life
WHAT WE OFFER!

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, Kabi Track, 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Assigns newly implemented documents for training and archives superseded documents in Learning management system (LMS).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…