R&D Associate Specialist

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

Requirements

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

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k) to eligible employees
• Eligible to participate in short-term incentive programs