R&D Documentation & Lab Operations Specialist

PowerToFly; New Jersey; On-site; USD 55,000 - 85,000; Full time

Benefits offered by this job

401(k) plan

Paid time off

Health insurance

Job summary

AbbVie seeks a detail-oriented professional to manage local R&D documentation and records in Branchburg, ensuring GDP-aligned practices and robust archival processes. You will generate tracking metrics, coordinate with stakeholders, and maintain electronic documentation systems while supporting audits and cross-functional teams.

The role requires a technical degree and 1–3 years’ experience, with preference for medical device or pharmaceutical industry background.

Qualifications

• Bachelor’s Degree in a technical field
• 1-3 years of experience
• Medical device or pharmaceutical industry experience preferred

Responsibilities

• Maintain local R&D archive room in accordance with Quality System Requirements for R&D records and data.
• Establish, maintain, and present/report 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)
• 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
• Coordinate, track, and document chain of custody for office and lab-based materials
• 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

Skills

Communication

Organizational skills

Independent work

Education

Bachelor's degree in a technical field

Tools

Microsoft Office

SharePoint

Teams

Job description

AbbVie seeks a detail-oriented professional to manage local R&D documentation and records in Branchburg, ensuring GDP-aligned practices and robust archival processes. You will generate tracking metrics, coordinate with stakeholders, and maintain electronic documentation systems while supporting audits and cross-functional teams.

The role requires a technical degree and 1–3 years’ experience, with preference for medical device or pharmaceutical industry background.