Sr. QA Documentation Specialist
Initiate and/or coordinate document change controls, including associated supporting documentation.
Follow up to ensure changes are completed, properly closed out, and released in accordance with established procedures.
Ensure controlled documents are reviewed, approved, distributed, and maintained in compliance with internal quality procedures.
Monitor document review cycles and coordinate with document owners to ensure timely revisions, periodic reviews, and retirements as appropriate.
Support issuance and archival of controlled documents, ensuring traceability and compliance with applicable regulations.
Prepare and support document retrieval during inspections, audits, and regulatory submissions.
Train new users on document control systems, ensuring proper understanding of system functionalities.
Provide guidance on document control practices and procedures to all functional departments.
Act as a point of contact for document owners and stakeholders to ensure proper use of the document management system.
Generate and maintain reports for document control activities, ensuring accuracy and timely completion.
Track key performance indicators (KPIs) related to document lifecycle management, review timeliness, and change control efficiency.
5-7 years of relevant experience in bio-pharmaceutical environment Quality Systems.
Experience with Veeva QualiySuite Platforms (Veeva QualityDocs, VaultTraining, Veeva QMS).
Bachelor of Science in Life Sciences, Engineering, or related discipline.
Ability to work in a team environment, manage multi-tasking, and discipline in completing tasks on schedule.
Excellent written and verbal communication skills.
Proficient in Microsoft Office skills (WORD, Excel, PowerPoint).
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