R&D Associate Specialist

Allergan; Branchburg Township, Northern (NJ, KY); Hybrid; USD 55,000 - 75,000; Full time

Job summary

AbbVie is seeking a detail-oriented R&D Documentation Specialist in Branchburg, NJ to manage local records, support lab operations, and ensure GDP-compliant documentation practices.

You will maintain the archive, coordinate with cross-functional teams, prepare materials for audits, and support EHS/continuous improvement initiatives in a regulated biotech environment. Bachelor’s degree and 1–3 years’ experience are preferred.

Qualifications

• Bachelor’s degree in a technical field.
• 1–3 years of experience in a lab or R&D setting.
• Experience in medical device or pharmaceutical industry preferred.

Responsibilities

• Maintain local R&D archive room in accordance with GDP and Quality System Requirements.
• 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.

Skills

MS Office Suite

SharePoint

Teams

Documentation in regulated environment

Education

Bachelor's Degree in a technical field

Tools

EDMS software

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 at www.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 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

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,andwemayultimatelypaymore 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, anddeterminable.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 withapplicable 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, visit https://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