Document Control Specialist Job in Hamilton L8s 4K1, Ontario Canada

Document Control Specialist

 

The Centre for Probe Development and Commercialization (CPDC) is a Centre dedicated to fostering the development, translation, and commercialization of molecular imaging probes and associated technologies. The Centre is seeking outstanding applicants for a Document Control Specialist.


Overview

The CPDC is looking for a motivated individual with experience in document control gained from working for a Health Canada, ISO or FDA regulated company.

 

Responsibilities

·       Manage controlled document system for product development, quality and regulatory

·       Develop and maintain controlled document templates

·       Review and format controlled documents prior to document approval

·       Provide data review for regulatory submissions and reports

·       Maintain master files for controlled documents

·       Scan controlled documents and completed batch records into Document Storage System

·       Maintain files for vendors, projects, submissions and raw data

·       Coordinate and track completion of training associated with implementation of new and revised controlled documents

·       Assist regulatory affairs in the collation and document preparation for Health Canada submissions


Qualifications

·       University degree in Science with a post-graduate diploma in Information Management, Regulatory, or a related discipline

·       Knowledge of the Regulatory requirements for the pharmaceutical industry with a minimum of 3 years experience in a pharmaceutical industry environment

·       Superior level skills in Microsoft Word, Excel, PowerPoint, document management systems

·       Ability to work in a fast paced and demanding environment

·       Organizational ability to maintain a complex and high volume of technical information

·       Excellent interpersonal skills and communication skills (verbal and written)

·       Experience in quality assurance and/or quality control considered an asset


To apply please submit a cover letter and resume to: careers@imagingprobes.ca

 

Attention: 

Joe McCann, PhD

Director, Product Development and Quality

Centre for Probe Development and Commercialization (CPDC)

1280 Main Street West, NRB‐101

Hamilton, ON  L8S 4K1

 

We thank all applicants for their interest, but only those selected for interview will be contacted