Specialist, Quality Systems and Compliance – Document Management

Posted 2 weeks ago

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About the role

  • Quality systems specialist managing controlled-document lifecycles and compliance for Grifols, a global healthcare company. Supporting audits, archives, GDP, cGMP, and electronic document systems.

Responsibilities

  • Maintain and administer the site's document management system
  • Coordinate the complete lifecycle of controlled documents, including SOPs, forms, work instructions, specifications, and quality records
  • Review documents for compliance with formatting standards, regulatory requirements, and internal procedures
  • Manage Document Management System requests and monitor associated timelines
  • Coordinate document review, approval, issuance, distribution, and obsolescence activities
  • Track periodic document reviews and follow up with document owners
  • Manage the archive system according to retention requirements and internal procedures
  • Administer the archive room and coordinate document retrieval, storage, transfer, and destruction
  • Coordinate the issuance, control, reconciliation, and maintenance of GMP logbooks
  • Oversee controlled printing, including issuance, tracking, and reconciliation
  • Maintain document control metrics and prepare quality system monitoring reports
  • Support internal audits and regulatory inspections by providing required documentation and records
  • Train and guide employees on document management procedures and Good Documentation Practices
  • Participate in continuous improvement initiatives related to document management and quality systems
  • Comply with cGMP requirements, quality procedures, and departmental safety practices

Requirements

  • Bachelor's degree in Science, Engineering, Business Administration, or a related field, or an equivalent combination of education and experience
  • Minimum of four years of experience in a regulated environment such as pharmaceutical, biotechnology, medical device, or related industries
  • Strong experience in document control, document management, or quality systems administration
  • Working knowledge of cGMP regulations, Good Documentation Practices (GDP), and applicable regulatory requirements (FDA, Health Canada, EudraLex, PIC/S)
  • Experience with Electronic Document Management Systems (EDMS) and change control systems
  • Strong organizational skills with the ability to manage multiple priorities and deadlines
  • Excellent written and verbal communication skills
  • Bilingualism (French and English) required
  • English proficiency required for documentation exchanges and communications with Grifols sites outside Quebec and Canada, including Spain and the United States

Benefits

  • Regular Full-Time employment
  • International team at a global healthcare company
  • Work contributing to healthcare and improved health and well-being
  • Opportunities to participate in continuous improvement initiatives
  • Training and guidance provided to employees on document management procedures and Good Documentation Practices (GDP)

Job title

Job type

Full Time

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

OnsiteMontrealCanada

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