Quality Systems Specialist

hace 4 días

Santiago de Chile Signant Health A tiempo completo

This could be the Opportunity of Your Life
Signant Health is a global evidence generation company. We’re helping our customers digitally enable their clinical trial programs, meeting patients where they are, driving change through technology and innovations and reimagining the path to proof.
Working at Signant Health puts you in the very heart of the world’s most exciting sector - a high-growth, dynamic company in an extraordinary industry.
Where do you fit in?
**As part of our team, your main responsibilities will be**:
1. Monitor QMS performance, implement improvements, and troubleshoot issues.
2. Manage user accounts, roles, permissions, and access controls within the QMS.
3. Provide support to QMS users across departments.
4. Generate and analyze quality metrics and reports from the QMS.
5. Manage document control processes and workflows.
6. Train staff on document control processes.
7. Manage training materials and documentation.
8. Coordinate with management to identify training priorities.
9. Ensure training is appropriately assigned.
10. Other project work and responsibilities as required.
**You’ll need to bring**:
1. 3+ years of Quality experience in a Life Sciences or related field.
2. Excellent verbal and written communication skills, including technical writing capability.
3. Excellent organizational and time management skills.
4. Critical thinking skills, including technical troubleshooting and problem-solving.
5. Deep understanding of quality management principles.
6. Risk assessment and mitigation abilities.
7. Strong presentation and facilitation skills, including ability to explain technical and quality concepts to various audiences.
8. Adaptability and willingness to learn new technologies and regulations.
9. Self-motivated with the ability to work independently.
10. Customer service orientation.
**We’d be thrilled to hear that you also have**:
1. Experience with validation of computer systems in regulated environments.
2. Experience with electronic QMS solutions (Dot Compliance, MasterControl, TrackWise, Veeva, etc.).
3. Knowledge of regulatory requirements for documentation (ISO, FDA, cGMP, etc.).
4. Experience with Learning Management Systems (LMS).
**Location**: Santiago, RM, Chile.
**Language**: Resumes must be submitted in English.
LI-IM1
At Signant Health, accepting difference isn’t enough—we celebrate it, we support it, and we nurture it for the benefit of our team members, our clients and our community. Signant Health is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status.

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