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Qa Control Documents Senior Coordinator

3+ years
Not Disclosed
10 Nov. 11, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

QA Control Documents – Senior Coordinator

Category: Regulatory / Compliance
Job ID: 255639
Locations: Available in 2 locations


Summary of Responsibilities

  • Follow all relevant departmental Standard Operating Procedures (SOPs) and Work Instructions (WIs).

  • Complete mandatory trainings within the required timelines.

  • Administer and maintain controlled documents, ensuring availability to end users.

  • Track, monitor, and report operational metrics as assigned by management.

  • Support implementation of new or revised processes and procedures.

  • Communicate effectively with internal stakeholders.

  • Perform quality checks to ensure accuracy and compliance.

  • Escalate and resolve issues affecting document release in a timely manner.

  • Ensure full compliance with Regulatory Compliance (RC) and Quality Assurance (QA) requirements as per controlled documents.

  • Perform additional duties as assigned.


Minimum Qualifications

  • 3 years’ experience in a regulatory environment (GxP roles preferred).

  • Strong skills in planning, prioritization, and organization.

  • Excellent attention to detail.

  • Strong analytical and communication skills.

  • Ability to work with computers and departmental digital tools.

  • Fortrea may consider equivalent experience in place of formal education.


Minimum Experience Requirements

  • Minimum 3 years' experience in a GxP-regulated environment.

  • Strong interpersonal skills and ability to collaborate effectively.

  • Consistently delivers high-quality work.

  • Proficient in using company systems, tools, and document-management platforms.


Physical Demands / Work Environment

  • Role requires sitting for long hours and working on a computer terminal throughout the workday.

  • Standard office / remote work environment.


About Fortrea

Fortrea is a global Contract Research Organization (CRO) operating in nearly 100 countries. With decades of expertise across 20+ therapeutic areas, Fortrea provides advanced clinical development and technology solutions for pharmaceutical, biotechnology, and medical device partners.

The company promotes the Fortrea FOUR culture:

  • Forward Together

  • Own It

  • Uphold Integrity

  • Respect People

Fortrea fosters a collaborative, growth-oriented work environment where employees contribute to accelerating the development of life-changing therapies.