Fortrea PhD Life Science Job as Functional Quality Specialist – Apply Now
Company Overview:
Fortrea is seeking a Functional Quality Specialist I to join our team. We are dedicated to providing top-quality service to all our clients, both internal and external, in a safe and cost-effective manner.
Job Posting: Functional Quality Specialist I
Job Overview:
The Functional Quality Specialist I will be responsible for performing quality reviews of assigned cases, compiling quality metrics, addressing client quality reviews, preparing corrective and preventive actions, ensuring CAPA results are implemented, and more.
Summary of Responsibilities:
- Perform quality reviews of safety cases and regulatory documents
- Compile quality metrics, identify trends, and support client quality reviews
- Contribute to CAPA preparation, implementation, and documentation
- Review global safety reports and regulatory documents (e.g., PSURs, PADERs, CSRs)
- Support quality processes across clinical and post-marketing safety data
- Manage adverse event reports, product complaints, and medical info queries
- Ensure compliance with timelines and regulatory requirements
- Participate in audits, inspections, and development of Quality Management Plans
- Design and track training for new and existing staff
- Analyze data for process improvement and support continuous quality enhancement
- Review/respond to medical queries and perform case intake follow-ups
- Guide safety associates and support call management
- Perform additional support activities such as data reconciliation, tracking, and QC
- Collaborate with project teams to ensure audit readiness and regulatory support
Qualifications (Minimum Required):
- Bachelors/Masters/PhD degree in Medicine or Alternative medicine, Medical Science, Pharmaceutical science, Nursing, Life Sciences, Biological Sciences, or related area.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience:
- 2+ years of experience in pharma, biotech, or CRO, mainly in Pharmacovigilance/Safety writing with some peer/quality review
- Strong cross-functional communication and problem-solving skills
- Familiarity with medical terminology, GCP, GVP, and ICH guidelines
- Understanding of global regulatory requirements for adverse event reporting (EU & FDA)
- Proficient in case processing and safety assessment
- Skilled in Microsoft Office tools
Preferred Qualifications Include:
- Experience in generating quality metrics
- Knowledge of Medical Device reporting
Physical Demands/Work Environment: Office Environment or remote. Travel may be required.
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