QA Specialist

Summary of Responsibilities:

• Tracking and Progression of Quality Issue.
• Development and delivery of training (to operational groups).
• Provide advice and guidance on aspects of quality and compliance.
• Provide consultation to the operational team on quality issues workflow.
• Cross-site QA and operational relationship, provide recommendations for improving compliance and/or efficiency.
• Work with operational management to support Quality topics and/or working on projects with QA team on other sites [showing development of collaboration skills].
• Manage local Quality initiatives aimed at improving compliance and/or efficiency of the local QA organization.
• 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):

• Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience).
• Experience may be substituted for education.

Experience (Minimum Required):

• 6 years in regulatory environment (experience in GXP roles).
• Experienced GXP auditor.
• Able to influence QA strategy.
• Ability to communicate with groups.
• Knowledge of multiple operational areas.
• Knowledge of industry quality systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios.

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.