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Qa Controlled Docs Sr. Coord

2+ years
Not Disclosed
10 March 19, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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 Overview:

Fortrea is seeking a Controlled Document Administrator to support the management and release of controlled documents in a regulatory environment. This position will involve ensuring compliance with departmental SOPs, administering controlled documents, tracking metrics, and assisting with the implementation of new processes and procedures. The ideal candidate will have strong attention to detail, excellent communication skills, and a solid understanding of GxP roles in a regulatory environment.


Key Responsibilities:

  • Follow and adhere to departmental Standard Operating Procedures (SOPs) and Work Instructions.
  • Complete required training within designated timelines.
  • Administer controlled documents, ensuring they are available to end users as needed.
  • Track and report metrics set by management according to required timelines.
  • Assist in implementing new or revised processes and procedures.
  • Demonstrate effective communication skills in all aspects of work.
  • Perform checks to ensure the quality of completed work.
  • Escalate and resolve any issues impacting the release of controlled documents in a timely manner.
  • Ensure that Regulatory Compliance and Quality Assurance (RC and QA) responsibilities are followed, as outlined in applicable controlled documents.
  • Perform other duties as assigned.

Qualifications:

Minimum Required Experience:

  • 2 years of experience in a regulatory environment, specifically in GxP roles.
  • Strong planning, prioritization, organizational, and communication skills.
  • Attention to detail with strong analytical skills.
  • Proficiency in using computer systems and departmental tools.

Physical Demands & Work Environment:

  • This role requires sitting at a terminal for extended periods during the workday.

Why Join Fortrea?

At Fortrea, we are dedicated to ensuring high-quality results in clinical trials and making a global impact. If you're a detail-oriented, self-motivated professional, you’ll find opportunities for growth and contribution in a collaborative team environment.


Fortrea is an Equal Opportunity Employer:

We encourage individuals from diverse backgrounds to apply. We do not tolerate discrimination or harassment and make employment decisions based on qualifications and business needs.


For more information about our Equal Employment Opportunity (EEO) policies and accommodations, please visit EEO & Accommodations Request.


Apply Now and Make an Impact at Fortrea!