R&D Associate Specialist

Manage Local R&D Documentation & Records:
Maintain local R&D archive room in accordance with Quality System Requirements for R&D records and data (e.g. paper records, histology slides and blocks)
Establish, maintain, and present/report out tracking metrics for local records and status (batch records, studies, technical documents)
Oversee histology slide requests/records, check-in & check-out, coordination with stakeholders and pre-clinical study data owners
Coordinate and track off-site physical documentation archival and retrievals
Author and own instructions and/or training materials related to local practices in alignment with global and department processes
Create and organize files in Electronic Documentation Management Systems (EDMS)
Collaborate with AbbVie document management groups and ad-hoc audit support
Ad-hoc scanning of paper records and preliminary review for compliance to Good Documentation Practices (GDP)
Lab and Technical Tasks:
Conduct receiving inspections of R&D materials including visual inspections, certificate of compliance reviews, completion of inspection documentation comparing to technical specifications and purchase orders
Perform sample preparation, sample labels, and may assist in testing/data generation
May assist in preliminary data analysis and technical writing
Support staff for coordination of on-going compliance for qualified processing and testing equipment
Track and organize physical tools, fixtures, and materials
Back-up host for visiting contractors performing work in the lab
Support EHS and continuous improvement initiatives
R&D Operations & Logistics Support:
Coordinate, track, and document chain of custody (as needed) for office and lab-based materials (in & outbound shipments)
Work with Development Excellence Team on implementation of new tools, trackers, and dashboard reports
Ad-hoc projects and support to the Branchburg Regenerative Medicine R&D teams
Education and Experience
Bachelor’s Degree in a technical field
1-3 years of experience
Medical device or pharmaceutical industry experience preferred
Other Professional Skills:
Proficiency with Microsoft Office Suite, SharePoint, Teams
Excellent written and oral communication skills
Experience working in a lab environment
Experience working with technical professionals
Experience working in a regulated industry and Good Documentation Practices
Excellent organization skills
Excellent attention to detail
Ability to manage multiple tasks
Ability to work independently and collaborate with others
Problem solving and continuous improvements for efficiency

Employment type
Full-time

Work arrangement
No