The QA Controlled Docs Sr. Coordinator manages controlled documents, ensures compliance with regulatory standards, tracks metrics, and handles issue resolution related to document releases.
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.
Top Skills
Document Management Systems
Gxp
MS Office
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