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.
• Ability to participate in process improvement initiatives and assist with implementation of new/revised processes and procedures.
• Ability to train others using developed materials.
• 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.
• Other duties as needed or assigned.

Qualifications (Minimum Required):

• 6 - 8 years in regulatory environment (experience in GXP roles).
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• Veeva (Quality & Clinical).
• Drafting Change controls and deviations.
• Document management and control.
• Demonstrated ability to plan, prioritize, organize and communicate effectively.
• Demonstrated ability to pay attention to detail.
• Strong interpersonal skills with ability to work well with others.
• Ability to deliver consistent high quality of work.
• Ability to use computer and departmental tools.
• Ability to participate in process improvement initiatives.
• Ability to facilitate meetings.

Physical Demands/Work Environment:

• Tasks involve sitting in front of a terminal for many hours during the working day.

Learn more about our EEO & Accommodations request here.