Document Control Specialist, Quality Assurance

6 days ago


Québec, Canada Institut de Cardiologie de Montréal Full time

Document Control Specialist, QUALITY ASSURANCE
**Document Control Specialist**, QUALITY ASSURANCE**

**Full Time**

**_Montreal Health Innovations Coordinator Center_**

The Montreal Health Innovations Coordinating Center (MHICC) is a full service contract research organization targeted on multicenter and multinational clinical trials. We provide services to the academic community and to the pharmaceutical, biotechnology and medical device industries. Our main goal is to establish a partnership with our customers to ensure a successful implementation of their project while respecting the scope of work, budget, timelines and highest standards of quality.

**WORK CONDITIONS**
- 35 hours weekly base
- Pre-approved overtime paid
- Flexible work schedule for work-family balance
- Hybrid model (working from home and office)
- 4 weeks’ vacation after one year
- 13 statutory holidays
- Defined retirement benefits
- Group insurance
- 9.6 day off sick days

**RESPONSIBILITIES**
- Serves as primary document control and archive administrator
- Works with the Head QA to establish and execute document control procedures
- Performs proofreading, editing, word processing, and filing to support the Quality Assurance department
- Creates and maintains filing systems (electronic and paper) for QA documents
- Maintains document number issuance logs for but not limited to deviations, NCF, CAPA, Change Control, SOP, and Protocols
- Creates and maintains employee training files
- Assists SOP owner on the preparation and performance of required SOP training
- Manages employee training program and performs periodic review of all training files
- Supports the clinical research team with the archival of documents and records such that documentation and files are accurate, complete and well organized
- Performs drawer assignation in the Documentation Room
- Maintains cleanliness and organization of Documentation Room to ensure audit and inspection readiness
- Manages and maintains archive program ensuring compliance with SOPs and processes, and all applicable regulations, ensuring adherence to specific records retention schedules
- Organizes and verifies submissions for archiving in accordance with Standard Operating Procedures
- Submits retrieves, and maintains archive documents as requested to / from external contract archive, and ensures that records or documents retrieved from archive are returned promptly
- Maintains applicable archive database and electronic records
- Assists with archive retrieval for audits and inspections
- Provides process improvements for archiving and document control by recognizing continuing issues and bringing them to the Head, QA’s attention
- Assists in writing of SOPs related to document control and archive management
- Provides cross-functional support within QA department, as needed
- Performs other duties as assigned by Head, QA

**REQUIREMENTS**
- DEC in sciences or equivalent diploma Master’s or Bachelor’s degree in life sciences or related discipline and Minimum of two (2) years of document management and archiving experience in the pharmaceutical, biotechnology or contract research organization (CRO)
- Bilinguisme (French/English)
- Computer literacy and proficient in Microsoft Office including Excel
- Organizational and interpersonal skills. Ability to initiate assigned tasks and work independently.

**TO SUBMIT YOUR APPLICATION**

We offer equal employment opportunities to all.



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