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QA Documentation Specialist

QRC GroupCidra, Puerto Rico

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Overview

Schedule
Full-time
Career level
Senior-level
Remote
On-site

Job Description

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

• * Bachelor’s degree completed.
• * 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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FAQs About QA Documentation Specialist Jobs at QRC Group

What is the work location for this position at QRC Group?
This job at QRC Group is located in Cidra, Puerto Rico, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at QRC Group?
Employer has not shared pay details for this role.
What employment applies to this position at QRC Group?
QRC Group lists this role as a Full-time position.
What experience level is required for this role at QRC Group?
QRC Group is looking for a candidate with "Senior-level" experience level.
What is the process to apply for this position at QRC Group?
You can apply for this role at QRC Group either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.