To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL - www.linkedin.com/in/deepak-arya-8a79aa22a/ ), email your updated resume at Email - deepak.arya@collabera.com . Thank you!
We are seeking a detail oriented Documentation Specialist to manage product documentation requests from receipt through approval in a document management system. The role supports GxP documentation and ensures records are processed accurately and within required timelines. The ideal candidate is a self starter with strong organizational and communication skills who can manage priorities with minimal oversight. The role also supports records management, process improvements, and cross functional activities in a matrixed environment.
Key Responsibilities:
Process GxP documents through document management systems from receipt to approval. Review documentation for completeness, accuracy, and required timelines. Maintain records and support archival and retention activities in compliance with applicable policies. Track documentation requests and follow up with stakeholders. Support purchasing, equipment tracking, and related administrative activities as needed. Work with cross functional teams in a matrixed environment. Identify opportunities to improve documentation workflows and processes.
Required Qualifications:
Strong organizational, communication, and attention to detail skills. Ability to work independently and execute tasks with minimal oversight. Experience processing and managing controlled or GxP documents. Proficiency with MS Office, including Word and DocX. Ability to manage shifting priorities and meet documentation timelines. High school diploma or equivalent and or relevant experience.
Preferred Qualifications:
Experience with DocXTool, OneVault, or PowerApps. Experience implementing process or workflow improvements. Exposure to AI applications for process improvement. Experience supporting GLP or GMP environments. Flexibility to support schedules spanning EU sites through West Coast US time zones.
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)