Job Description

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