Job Description – QA Controlled Documents Associate
Location: Mumbai & Bangalore
Category: Regulatory/Compliance
Job ID: 25676
Company: Fortrea
Company Overview
Fortrea is a leading global contract research organization (CRO) providing clinical development, patient access, and technology solutions across 20+ therapeutic areas. Operating in ~100 countries, Fortrea is transforming drug and device development to improve patient outcomes worldwide.
Role Overview
The QA Controlled Documents Associate is responsible for managing and maintaining controlled documents within Fortrea’s Quality Management System (QMS). This role involves document administration, compliance tracking, process improvement initiatives, and training support, ensuring adherence to regulatory and quality standards.
Key Responsibilities
Document Management & Compliance
Administer and maintain controlled documents, ensuring availability to end users.
Follow departmental Standard Operating Procedures (SOPs) and Work Instructions (WIs).
Track and report key document control metrics as determined by management.
Ensure Regulatory Compliance and Quality Assurance (RC & QA) requirements are met.
Perform quality checks to ensure document accuracy and compliance.
Process Improvement & Issue Resolution
Participate in process improvement initiatives and assist with implementing new/revised processes.
Escalate and manage issues impacting controlled document release in a timely manner.
Support resolution management to maintain compliance and efficiency.
Training & Communication
Develop and train others using structured materials and guidelines.
Facilitate meetings and effectively communicate updates to stakeholders.
Maintain strong interpersonal skills to collaborate effectively with internal teams.
Required Qualifications & Experience
Education:
Bachelor’s degree required (or relevant equivalent experience).
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience:
4 years of experience in a regulatory environment (GXP roles preferred).
Skills & Competencies:
Strong organizational and prioritization skills.
High attention to detail and ability to produce high-quality work.
Excellent communication skills (verbal & written).
Ability to facilitate meetings and work collaboratively across teams.
Proficiency in computer systems and departmental tools.
Work Environment & Physical Demands
Office-based role requiring extended hours in front of a computer.
About Fortrea
Fortrea is committed to advancing clinical trials and regulatory compliance through innovation and collaboration. We foster a diverse and inclusive work environment, empowering professionals to make a global impact.
Equal Opportunity Employer Statement
Fortrea is an Equal Opportunity Employer (EOE/AA) and does not tolerate discrimination based on race, gender, disability, veteran status, or any other legally protected category.
For more details, visit www.fortrea.com.
If you require accommodations during the hiring process, please contact taaccommodationsrequest@fortrea.com.
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