R&D Associate Specialist

AbbVie•Branchburg Township, NJ

1d•$58,656 - $99,000

About The Position

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. This role will manage local R&D documentation and records, conduct lab and technical tasks, and provide R&D operations and logistics support.

Requirements

Bachelor’s Degree in a technical field
1-3 years of experience
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

Nice To Haves

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 (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)
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 (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