Scientist, Inhalation Reserach and Development-NC (Technical Review and Electronic Systems Support) jobs in United States
cer-icon
Apply on Employer Site
company-logo

Aurobindo Pharma USA, Inc. ยท 3 months ago

Scientist, Inhalation Reserach and Development-NC (Technical Review and Electronic Systems Support)

positionDurham, North Carolina
timeFull-time
remoteOnsite
seniorityMid, Senior Level
date6+ years exp

Aurobindo Pharma USA, Inc. is a generic pharmaceutical manufacturer and distributor committed to delivering quality, affordable pharmaceuticals. The Scientist in Inhalation Research and Development will perform technical reviews of laboratory experimentation, ensuring compliance with internal procedures and cGMPs, while also providing support for the electronic laboratory notebook system.

BiotechnologyPharmaceutical
check
H1B Sponsor Likelynote

Responsibilities

Reviews experimental documentation for accuracy, completeness, and compliance with internal procedures
Reviews reports for accuracy and completeness
Maintain the document review metrics to ensure that books are completed, submitted for review, reviewed, and closed to meet internal procedures and expectations
Provides coaching to less experienced analysts to improve compliance and throughput
Support deployment of the electronic laboratory notebook system through training, validation script review, and validation protocols and reports

Qualification

GMP laboratory experienceTechnical review experienceElectronic laboratory notebookSoftware validation reviewOral communication skillsWritten communication skillsTeam collaborationMentoring skills

Required

GMP laboratory experience for execution and documentation of testing and technical review of documentation is required
Previous GMP laboratory experience and technical reviewer experience are required
Should be able to read and understand SOPs, test methods, protocols and other governing documents to ensure that work conducted is in alignment and compliant
Must be able to monitor for compliance with project timelines for completion of notebooks and interact effectively with management to secure resources needed to drive completion
Must be able to lead/mentor others on documentation and documentation review
Must possess excellent oral and written communication skills and be able to thrive in a team environment
BS in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field plus 6 years combined laboratory and review experience. At least three years in a GMP environment

Preferred

Review experience within an electronic laboratory notebook system is preferred
Experience with management and qualification of electronic systems preferred
Previous experience with reviewing software validation scripts and documents is preferred

Company

Aurobindo Pharma USA, Inc.

twittertwitter
company-logo
Aurobindo Pharma is a pharmaceuticals company offering generic pharmaceuticals.
dateFounded in 1992
location
Windsor, New Jersey, USA
people-size501-1000 employees
web-link
http://aurobindousa.com

H1B Sponsorship

Aurobindo Pharma USA, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (4)
2023 (4)
2022 (10)
2021 (9)
2020 (10)

Funding

Current Stage
Late Stage

Leadership Team

leader-logo
Swami Sambamurty Iyer
Chief Executive Officer
linkedin

Recent News

The Hindu
Aurobindo recalling over 4,600 bottles of pain relieving tablets in U.S.
2025-06-28
Business Standard India
Why has Aurobindo Pharma stock gained 3% in trade today, November 25?
2024-11-25
The Economic Times
Aurobindo joins hands with global pharma player to develop respiratory products
2024-11-24
Company data provided by crunchbase