R&D Associate 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

Company Description

About AbbVie

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. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

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

Qualifications

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 skillsExcellent attention to detail
• Ability to manage multiple tasks
• Ability to work independently and collaborate with others
• Problem solving and continuous improvements for efficiency

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,and wemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, and determinable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company’ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

What AbbVie Has to Offer

Our work can—and does—have a tangible, lasting impact on millions of people. But it’s not just the results that matter. How we achieve them matters, too. Leading with purpose, we work to build a more sustainable future for generations to come. We do that by putting our expertise, resources and talent to work to make a real difference for patients, communities and our world.