QA Documentation Specialist

Zohorecruit

Puerto Rico

On-site

USD 60,000 - 80,000

Full time

9 days ago
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Job summary

Zohorecruit in Cidra, Puerto Rico is seeking a Quality Documentation Specialist with strong GMP documentation and quality systems expertise. You will review, approve, and maintain critical GMP documentation, ensuring compliance and readiness for regulatory inspections.

Join a cross-functional team to implement document revisions, manage document control systems, and train staff on procedures. This role emphasizes accuracy, organization, and independent work in a fast-paced environment.

Qualifications

  • Minimum 5 years of experience in GMP documentation and quality systems.
  • Proficiency with document control platforms and Microsoft Office.
  • Excellent attention to detail and strong written communication.
  • Ability to work independently and across cross-functional teams.

Responsibilities

  • Review, approve, and maintain GMP documentation including batch records, protocols, CAPAs, NOEs, and change controls.
  • Ensure documentation aligns with regulatory requirements and internal quality standards.
  • Support internal audits, inspections, and document readiness for regulatory agencies.
  • Collaborate with cross-functional teams to implement document revisions and updates.
  • Manage document control systems and ensure timely issuance and archiving of controlled documents.
  • Assist in training personnel on documentation procedures and compliance practices.

Skills

GMP documentation
Quality systems
Document control
Microsoft Office
Written communication
Attention to detail
Organizational skills
Independent work

Tools

Document control platforms
Microsoft Office

Job description

Cidra, Puerto Rico | Posted on 09/23/2026

Quality Documentation Specialist with strong expertise in GMP documentation and quality systems. This role blends traditional QA responsibilities with a focus on managing, reviewing, and controlling documentation to support compliance and operational excellence.

Key Responsibilities
  • Review, approve, and maintain GMP documentation including batch records, protocols, CAPAs, NOEs, and change controls.
  • Ensure documentation aligns with regulatory requirements and internal quality standards.
  • Support internal audits, inspections, and document readiness for regulatory agencies.
  • Collaborate with cross-functional teams to implement document revisions and updates.
  • Manage document control systems and ensure timely issuance and archiving of controlled documents.
  • Assist in training personnel on documentation procedures and compliance practices.
Requirements
  • Minimum 5 years of experience.
  • Strong background in GMP documentation and quality systems.
  • Proficiency in document control platforms and Microsoft Office tools.
  • Excellent attention to detail, organizational skills, and written communication.
  • Ability to work independently and in cross-functional environments.
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