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Functional Quality Specialist I

2+ years
Not Disclosed
10 Oct. 22, 2024
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

Job Posting: Quality Assurance Specialist at Fortrea

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients worldwide.

Key Responsibilities:

  • Perform quality review of assigned cases.
  • Assist in compiling quality metrics based on reviews and identifying quality trends.
  • Support periodic client quality reviews.
  • Aid in the preparation of Corrective and Preventive Actions (CAPA) as requested.
  • Ensure implementation of CAPA results and provide documentary evidence in coordination with project managers.
  • Conduct ongoing reviews of various cases or safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, and Clinical Study Reports.
  • Manage expeditable adverse events, product quality complaints, and medical information to required standards.
  • Assist in process reviews and monitor audit readiness.
  • Design and track training schedules and materials for new hires and existing team members.
  • Participate in discussions on quality errors and help identify process improvements.
  • Support client or external audits of assigned projects as needed.
  • Contribute to the development of Quality Management Plans for assigned projects.
  • Coordinate with project teams during regulatory inspections with support from Quality Leads.
  • Analyze data and suggest strategies for process improvement.
  • Respond to medical information queries and product quality complaints received via various channels.
  • Execute drug safety data management processes, including call intake reviews and case follow-ups.
  • Guide safety associates in managing voice calls as needed.
  • Perform additional support activities, such as tracking metrics and ongoing quality control of defined processes.
  • Contribute to process reviews to identify improvement initiatives.
  • Review product quality complaints and respond as per agreed procedures.

What We Offer: Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Equal Opportunity Employment: Fortrea is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual, without discrimination based on race, religion, color, national origin, gender (including pregnancy or medical conditions), family status, marital status, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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