Summary of Responsibilities:
- Works with internal teams to progress quality issues in QMS.
- Tracks timeliness of cases in QMS.
- Supports teams in creation of CAPAs.
- Maintains strong working knowledge of QMS.
- Interacts with QA Lead Manager and above as required for quality issue case progression and client notifications.
- Supports QA Lead Manager and above in pulling metric data, trending, and tracking of QI.
- All other duties as needed or assigned.
Qualifications (Minimum Required):
- A minimum of a bachelor’s degree in Life Sciences preferred (or equivalent Life Science experience).
Experience (Minimum Required):
- 8 years in regulatory environment (experience in GXP roles).
- Strong understanding of QMS and CAPA process.
- Ability to work well within a team environment.
- Convey key details of quality issues internally.
- Communicate quality issue summary to clients where applicable.
- Knowledge of GCPs/GxPs.
Preferred Qualifications Include:
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Physical Demands/Work Environment:
- Travel may be required.
- Office-Based (Hybrid), as requested by the line manager.
Learn more about our EEO & Accommodations request here.
Skills Required
- Bachelor's degree in Life Sciences (or equivalent experience)
- 8 years in a regulatory environment with GxP experience
- Strong understanding of QMS and CAPA process
- Knowledge of GCPs/GxPs
- Ability to work well within a team environment
- Ability to convey key details of quality issues internally
- Ability to communicate quality issue summaries to clients where applicable
- Employer may consider relevant and equivalent experience in lieu of educational requirements
What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
