Position: QA Control Documents Senior Coordinator
Category: Regulatory / Compliance
Job ID: 255639
Locations: Available in 2 locations
About the Role
The QA Control Documents Senior Coordinator ensures controlled documentation processes comply with regulatory and quality standards. This role involves administering, tracking, and maintaining quality-controlled documents, ensuring their accuracy, accessibility, and regulatory compliance. The coordinator also contributes to process improvement and supports implementation of new and revised procedures.
Key Responsibilities
Adhere to all departmental Standard Operating Procedures (SOPs) and Work Instructions (WIs).
Complete all mandatory trainings within assigned timelines.
Administer and maintain controlled documents, ensuring accessibility for end users.
Track and report key metrics as determined by management within required deadlines.
Assist in the implementation of new or revised processes and procedures.
Conduct quality checks to ensure accuracy and compliance of documentation.
Escalate and manage issues affecting controlled document release in a timely manner.
Ensure all Regulatory Compliance (RC) and Quality Assurance (QA) responsibilities are executed in alignment with applicable controlled documents.
Communicate effectively with cross-functional teams to resolve documentation issues.
Perform additional duties as assigned by management.
Qualifications (Minimum Required)
Minimum 3 years of experience in a regulatory or GxP-compliant environment.
Proven ability to plan, prioritize, and organize work effectively.
Excellent attention to detail and commitment to quality.
Strong analytical and communication skills.
Proficient in using computers and departmental documentation tools.
Education: Relevant degree preferred; Fortrea may consider equivalent experience in lieu of formal education.
Experience (Minimum Required)
At least 3 years of hands-on experience in a regulatory or GxP-focused role.
Strong interpersonal skills and ability to collaborate across departments.
Demonstrated track record of producing consistent, high-quality work.
Work Environment & Physical Demands
Role involves long periods of computer-based work (sitting in front of a terminal for several hours daily).
Standard office-based setting; hybrid work options may apply per department guidelines.
About Fortrea
Fortrea is a global Contract Research Organization (CRO) with decades of experience advancing drug and device development. Operating in over 100 countries and spanning 20+ therapeutic areas, Fortrea partners with pharmaceutical, biotechnology, and medical device clients to accelerate the delivery of life-changing therapies.
Our culture — Forward Together, Own It, Uphold Integrity, and Respect People — defines how we collaborate, innovate, and deliver excellence worldwide.
🌐 Learn more: www.fortrea.com
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