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
.
