Document & Record Control Associate, Contractor

Celularity is a next-generation biotechnology company creating off-the-shelf allogeneic cellular treatments for cancer, infectious diseases, and degenerative diseases (www.celularity.com). Join our expanding quality team on our mission to lead the next evolution in cellular medicine at our state-of-the-art facility in Florham Park, NJ.

As a Document & Record Control Associate, Contractor, you will work across the organization as a direct liaison between all departments and our quality unit within the quality management system. You will be part of current quality processes for QxP documents and records, and have the opportunity to be part of future improvements and automation efforts for these processes.

1. Maintain GxP documentation, in both electronic and hard copy formats, for on-site Records Room and coordinate off-site storage: activities include records tracking, filing, copying, scanning, verifying, retrieving, indexing, boxing, storaging, archiving and destruction
2. Maintain compliance to quality management processes in accordance to governing regulations, requirements and standards
3. Control records using document tracking tools, ensure accuracy and traceability throughout quality records lifecycle
4. Control use, location, and record systems within the Records Room including ordering supplies, filing, scanning, logging, boxing, shipping records
5. Issue, track and reconcile logbook issuance
6. Provide document and record coordinator activities in the electronic Quality Management System (eQMS) and electronic Document Management System (Veeva)
7. Support Quality Systems governance for Deviations, CAPAs, Change Control and Quality Metrics.
8. Schedule and assign the review and completion of workflows for controlled documents and QMS records.
9. Responsible for tracking and completion of the processing, review, and approval of all revision-controlled documents
10. Ensure that all documentation within the group is completed to the highest quality standards
11. Support document periodic review for relevance and accuracy of procedures
12. Support implementation of Quality Management System improvements with management's guidance in moderate technical problem solving within function and/or cross functional areas
13. Provide input, improvement suggestions and updates of quality management processes
14. Ensure archive and retention policy is followed and documents are maintained in an organized and secure manner
15. Actively engages in continuous improvement for areas of responsibility, collaborating with other departments to identify and implement process efficiencies
16. Performs other QA duties as assigned.

• Bachelor's degree in a Life Science and Minimum of 1 year working quality experience within a GXP regulated field or function
• 1+ years of working experience within an overall quality function and prior records library operations experience preferred
• Prior GMP experience preferred.
• Proven ability to juggle multiple tasks and responsibilities while taking full ownership of work
• Ability to learn, follow procedures/instructions, and adapt in a regulated environment
• Excellent written and verbal communication skills internally and externally; communicate results and issues effectively
• Exceptional attention to detail with high degree of focus and ability to exercise judgement and make decisions
• Able to follow instructions and exercise judgment within defined procedures, both written and verbal
• Able to motivate compliance among peers; quality, customer focus
• Comfortable in a small, dynamic company environment
• Strong cross-functional relationships
• Able to perform with minimal supervision
• Good computer skills with solid experience in MS Office and Excel required
• Demonstrated success in maintaining composure and effectiveness in the face of competing and complex demands
• The incumbant must occasionally lift or move boxed files up to 25lbs and be able to use a step ladder for accessing files

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