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Qa Control Documents Senior Coordinator

3+ years
Not Disclosed
10 Nov. 13, 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

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