QA Controlled Documents Senior Coordinator
Locations: Multiple – 3 Locations (India)
Category: Regulatory / Compliance
Job ID: 255644
Experience Required: Minimum 3 years in a regulatory environment (GxP roles)
Job Overview
Fortrea, a leading global contract research organization (CRO), is seeking a QA Controlled Documents Senior Coordinator to manage, track, and ensure compliance of controlled documents within our regulatory and quality framework. This role is critical to maintaining Regulatory Compliance (RC) and Quality Assurance (QA) standards across global clinical development projects. The position is open across three locations in India and offers an opportunity to contribute to high-impact pharmaceutical, biotechnology, and medical device projects.
Key Responsibilities
Administer and manage controlled documents, ensuring availability to end-users and compliance with departmental SOPs and Work Instructions.
Track, report, and analyze document metrics as required by management within designated timelines.
Assist with the implementation of new or revised processes and procedures related to document control and quality compliance.
Conduct quality checks on all document-related tasks to ensure accuracy, completeness, and adherence to regulatory standards.
Escalate and manage document release issues, ensuring timely resolution to prevent project delays.
Ensure compliance with GxP regulations, RC, and QA responsibilities outlined in controlled documents.
Complete all required training programs on time and ensure documentation is up to date.
Support cross-functional teams with document-related inquiries and provide guidance on standard processes.
Perform any additional duties as assigned to support departmental and organizational objectives.
Required Qualifications & Experience
Education: Bachelor’s degree preferred; Fortrea may consider equivalent experience in lieu of formal education.
Experience: Minimum 3 years in a regulatory environment, preferably in GxP-compliant roles handling controlled documents, SOPs, or quality systems.
Proven ability to plan, prioritize, organize, and communicate effectively in a fast-paced environment.
Strong analytical skills and attention to detail, with a track record of delivering high-quality work consistently.
Proficiency in document management systems, Microsoft Office Suite, and other departmental tools.
Excellent interpersonal skills and ability to collaborate effectively across teams.
Work Environment & Schedule
Predominantly office-based, with extensive computer use.
Must be comfortable working 2nd shift hours (2 PM – 11 PM IST).
May involve interaction with global teams, requiring flexibility and adherence to timelines.
Why Join Fortrea
Fortrea is a global leader in clinical development, operating across ~100 countries and delivering innovative solutions for pharmaceutical, biotechnology, and medical device clients. Our culture—Forward Together, Own It, Uphold Integrity, Respect People (Fortrea FOUR)—fosters collaboration, personal growth, and meaningful contributions to global health.
As part of our team, you will work in a dynamic environment that champions scientific rigor, process excellence, and patient-centric innovation. Fortrea provides opportunities to develop your career while making a tangible impact on the delivery of life-changing therapies.
Learn more: www.fortrea.com
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