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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing Change Control and CAPA systems while ensuring compliance with cGMP and regulatory requirements. Proficient in conducting quality risk assessments, training employees, and maintaining documentation management systems.
Highest-signal resume keywords
Change Control ManagementCAPA Systems ManagementQuality Risk AssessmentRegulatory ComplianceSOP Development
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Risk AssessmentChange Control ManagementCAPA SystemsSOP DevelopmentData AnalysisCompliance ManagementQuality Deviation InvestigationDocumentation ManagementCGMP ComplianceRegulatory Guidelines Familiarity
Soft Skills
Excellent Communication SkillsProblem SolvingTraining and Coordination
Tools & Technologies
Documentation Management System
Industry Keywords
CGMPFDAEudralexPIC/sHealth Canada
About the role
Key responsibilities & impact- Manage Change Control and CAPA systems
- Perform assigned tasks related to quality risk assessments
- Support the risk team and help ensure consistent risk assessment practices
- Review and approve risk reports as required
- Prepare, review, and sometimes approve SOP revisions in the Documentation Management System
- Participate in quality deviation investigations
- Collect, review, and potentially analyze data
- Maintain compliance management files
- Address and resolve problems according to written procedures and SOPs
- Provide and coordinate support for compliance assessment owners
- Train employees as needed
- Initiate compliance assessments for the Quality area and document non-compliance
- Conduct periodic compliance reviews as necessary
- Follow cGMP and departmental safety practices
- Develop activities to reduce or mitigate non-compliance
- Coordinate work assignments and training of other employees as needed
- Report to the Quality System and Compliance Manager
Requirements
What you’ll need- BS/BA degree preferably in a STEM (science, technology, engineering or mathematics) curriculum and 4 years of related experience or equivalent combination of education and experience
- Excellent written and verbal communication skills
- Familiarity with domestic and applicable foreign regulatory agency requirements/guidelines, including Food and Drug Administration, Eudralex, PIC/s, and Health Canada
- English proficiency required for document exchanges and communications with Grifols sites outside Quebec and Canada
- Bilingualism in French and English preferred
Benefits
Comp & perks- 🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Grifols Website LinkedIn All Job Openings 10,000+ employees Founded 1909 🏥 Healthcare 🏭 Manufacturing 🧬 Biotechnology Healthcare
- Manufacturing
- Biotechnology Grifols is a global healthcare company dedicated to improving the health and well-being of people around the world. They focus on the development, production, and distribution of innovative plasma-derived medicines and have a strong commitment to research and development in the pharmaceutical sector. Grifols aims to provide solutions for patients with rare diseases and chronic conditions, contributing significantly to the field of biotechnology and healthcare. Specialist, Quality System and Compliance Job not on LinkedIn 🔥 2 minutes ago 🏢 Montreal – Onsite ⏰ Full Time 🟡 Mid-level 🟠 Senior 🚔 Compliance 👻 Ghost score 10% Apply Now Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
- Manage Change Control and CAPA systems
- Perform assigned tasks related to quality risk assessments
- Support the risk team and help ensure consistent risk assessment practices
- Review and approve risk reports as required
- Prepare, review, and sometimes approve SOP revisions in the Documentation Management System
- Participate in quality deviation investigations
- Collect, review, and potentially analyze data
- Maintain compliance management files
- Address and resolve problems according to written procedures and SOPs
- Provide and coordinate support for compliance assessment owners
- Train employees as needed
- Initiate compliance assessments for the Quality area and document non-compliance
- Conduct periodic compliance reviews as necessary
- Follow cGMP and departmental safety practices
- Develop activities to reduce or mitigate non-compliance
- Coordinate work assignments and training of other employees as needed
- Report to the Quality System and Compliance Manager 🎯 Requirements
- BS/BA degree preferably in a STEM (science, technology, engineering or mathematics) curriculum and 4 years of related experience or equivalent combination of education and experience
- Excellent written and verbal communication skills
- Familiarity with domestic and applicable foreign regulatory agency requirements/guidelines, including Food and Drug Administration, Eudralex, PIC/s, and Health Canada
- English proficiency required for document exchanges and communications with Grifols sites outside Quebec and Canada
- Bilingualism in French and English preferred Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score View More Compliance Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates About us Is Remote Rocketship legit? Privacy policy Terms of service Job board SEO course Remote Job Search MasterClass Resume Review AI Apply Copilot OpenClaw job finder API docs Find jobs using your resume Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs