Summary of Responsibilities:
- Follow applicable departmental Standard Operating Procedures and Work Instructions.
- Complete required trainings according to required timelines.
- Administer controlled documents ensuring availability to the end user.
- Track and report metrics as determined by management according to required timelines.
- Assist with implementation of new/revised processes and procedures.
- Demonstrated ability to communicate effectively.
- Perform checks to ensure quality of work completed.
- Ensure timely escalation and resolution management of issues impacting controlled document release.
- Ensure Regulatory Compliance and Quality Assurance (RC and QA) responsibilities, as indicated in applicable controlled documents, are followed.
- 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):
- 4 to 6 years in regulatory environment (experience in GXP roles).
- Strong knowledge of QMS, CAPA management, and Veeva Vault.
- Experience in audit processes is an added advantage.
- Strong interpersonal skills with ability to work well with others.
- Demonstrated ability to plan, prioritize, organize and communicate effectively.
- Demonstrated ability to pay attention to detail.
- Strong analytical skills.
- Ability to deliver consistent high quality of work.
- Ability to use computer and departmental tools.
Preferred Qualifications Include:
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Physical Demands/Work Environment:
- Office-based (5 days per week), as required by the line manager.
Learn more about our EEO & Accommodations request here.
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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.
