About the Role

The Quality Specialist, Document Controls is responsible for the end-to-end lifecycle management of controlled documents within a highly regulated clinical trial technology environment. This role ensures that all quality documentation — including Standard Operating Procedures (SOPs), Work Instructions (WINs), policies, forms, and associated records — is authored, reviewed, approved, distributed, and retired in strict accordance with GCP, FDA 21 CFR Part 11, EU Annex 11, and applicable ICH guidelines.

What you will do

The Specialist serves as a subject matter expert and primary point of contact for document control activities within the Quality Management System (QMS), supporting inspection readiness, audit preparation, and continuous improvement of the document management framework. The role acts as a critical enabler of quality culture and compliance confidence across the organization.

KEY ACCOUNTABILITIES

1. Document Lifecycle Management

- Own and manage the end-to-end lifecycle of controlled quality documents (SOPs, WINs, policies, templates, forms, and associated records) within the QMS — from initiation and authoring through to review, approval, periodic review, and retirement.
- Ensure all controlled documents are accurate, compliant, version-controlled, and accessible to relevant stakeholders at the appropriate time.
- Coordinate document reviews and approvals with document owners, subject matter experts (SMEs), and Quality leadership, tracking progress against due dates and escalating delays proactively.
- Manage document change control processes, ensuring all changes are assessed, justified, approved, and communicated in accordance with QMS procedures.
- Maintain and enforce document numbering conventions, naming standards, and metadata requirements within the QMS.

2. QMS System Administration & Compliance

- Serve as a system administrator or power user for the electronic Quality Management System (e.g. Dot Compliance, Veeva Vault, MasterControl, or equivalent), maintaining system configuration, user access, and workflow integrity.
- Ensure the QMS is operating in a validated state at all times in compliance with 21 CFR Part 11 and EU Annex 11 electronic records requirements.
- Manage system support tickets and resolve document control-related issues; elevate system defects to the QMS system owner as appropriate.
- Prepare and maintain QMS reports, dashboards, and metrics related to document status, overdue reviews, and compliance KPIs.

3. Training Assignment & Matrix Management

- Assign training requirements linked to new or revised controlled documents; maintain the training matrix and ensure training records are accurately captured and up to date.
- Monitor training completion rates and elevate non-compliance to document owners and functional management.
- Coordinate with HR and functional leads to ensure onboarding training curricula reflect current controlled documents.

4. Inspection Readiness & Audit Support





- Maintain document control records in a constant state of inspection readiness, supporting regulatory authority inspections (e.g. FDA, EMA, MHRA) and sponsor/customer audits at all times.
- Prepare document control-related sections of inspection/audit packs; retrieve requested documents and records in a timely and accurate manner.
- Support identification and remediation of document control findings arising from audits, quality events, and CAPAs.

5. Quality Events & CAPA Support

- Support the investigation of quality events where document control gaps or failures are identified as contributing factors.
- Author or contribute to Corrective and Preventive Actions (CAPAs) related to document control deficiencies, tracking actions through to effective closure.
- Perform or support CAPA effectiveness checks for document control-related actions.

6. Process Improvement & Governance

- Identify and recommend improvements to document control processes, templates, workflows, and QMS configuration to drive efficiency, compliance, and user adoption.
- Develop and maintain job aids, quick reference guides, and training materials related to document control procedures.
- Participate in periodic review of the Document Control SOP and associated Work Instructions, ensuring alignment with current regulatory expectations and internal practice.
- Support benchmarking of document control practices against industry best practice and regulatory guidance.

7. Stakeholder Support & Communication

- Act as the primary point of contact for all document control queries from internal stakeholders including Quality, Operations, Clinical, Regulatory Affairs, and IT.
- Provide guidance and training to document owners and authors on document control procedures, templates, and QMS system usage.
- Other project work and responsibilities as required.

DECISION MAKING AND INFLUENCE

The Quality Specialist, Document Controls exercises independent judgement on document formatting compliance, version control decisions, and routing of documents through the QMS workflow. The role escalates issues involving systemic QMS failures, inspection risk, or recurring non-compliance to the Senior Manager, Quality Systems Compliance. The Specialist influences document quality and regulatory compliance culture across all functions through consistent application of document control standards.

Preferred Qualifications

- 3–5 years of experience in a document control or quality systems role within a GCP-regulated environment (clinical trial technology, CRO, pharmaceutical, medical device, or biotechnology).




- Demonstrated experience managing controlled documents within an electronic QMS (e.g. Dot Compliance, Veeva Vault, MasterControl, or equivalent), including system administration capabilities.
- Working knowledge of ICH E6 (R2/R3) Good Clinical Practice, FDA 21 CFR Part 11, EU Annex 11, and ICH Q10 quality system requirements.
- Strong understanding of document lifecycle management principles including version control, change control, periodic review, and document retirement.
- Demonstrated ability to interpret and apply regulatory requirements to document control operations and QMS configuration.
- Excellent written communication skills with the ability to produce clear, precise, and compliant documentation.
- Proven ability to manage competing priorities, meet deadlines, and multi-task effectively in a fast-paced, deadline-driven environment.
- Demonstrated extreme attention to detail and a high degree of organisational discipline across all aspects of work.
- Experience supporting regulatory authority inspections and/or customer audits, including document retrieval and audit pack preparation.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and document management or ticketing systems.
- Ability to utilize Company-issued and approved Artificial Intelligence (AI) tools to support productivity, efficiency, and quality of work, while maintaining accountability for all AI-generated outputs.
- Experience with CAPA management processes and quality event investigation in a GCP environment.
- Familiarity with GAMP 5 principles and computerised system validation requirements for QMS platforms.
- Knowledge of Lean Six Sigma tools or ISO 9001 quality management principles.
- Experience developing training curricula, job aids, or SOPs related to document control.
- Exposure to eCOA, RTSM, or other clinical trial technology platforms and their associated quality documentation requirements.

Applicable Regulatory Frameworks

- ICH E6 (R2/R3) Good Clinical Practice
- FDA 21 CFR Part 11 (Electronic Records)
- EU Annex 11 (Computerised Systems)
- EU GDPR / Data Privacy

Applicable Standards & Guidance

- ICH Q10 Pharmaceutical Quality System
- ISO 9001 Quality Management
- GAMP 5 (Computerised System Validation)
- TITLE 21 CFR Part 820 (QSR)

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. We are proud to be an equal opportunity workplace and an affirmative action employer, 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.

Prior to their start date, all candidates are required to be verified through a thorough background check and identity verification to confirm eligibility for employment.

#J-18808-Ljbffr

📌 Quality Specialist Document Controls (Chile)
🏢 Signant Health
📍 Chile