QA Controlled Docs Sr Coordinator

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):

• 3 years in regulatory environment (experience in GXP roles).

• Demonstrated ability to plan, prioritize, organize and communicate effectively.

• Demonstrated ability to pay attention to detail.

• Strong analytical skills.

• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• 3 years in regulatory environment (experience in GXP roles).

• 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.

Physical Demands/Work Environment:

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

• Should be comfortable working in 2nd shift hours (2 - 11 PM IST)