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R&D Partners · 1 day ago

Associate Stability Research Scientist II

Durham, NC

Contract

Onsite

Entry, Mid Level

$78K/yr - $85K/yr

1+ years exp

R&D Partners is a global functional service provider specializing in scientific, clinical research & engineering, and they are seeking an Associate Stability Research Scientist II. The primary responsibilities include maintaining product inventory for stability studies, coordinating with packaging for sample acquisition, and ensuring compliance with GMP requirements.

Staffing Agency

Hiring Manager

Emily Filepas

Responsibilities

Daily, maintain product inventory for active stability studies in accordance with all compliance requirements by assuring the accountability and delivery of all stability samples and associated documentation as well as the issuance of required documentation for testing

Coordinate with Packaging to acquire samples for batches to be placed into the stability program for evaluation

Maintain label printers in good working order to ensure ability to fulfill printing of labels for stability requests

Maintain and audit all sample labeling and documentation for accuracy and compliance with GMP

Facilitate delivery of stability samples for laboratory testing and coordinate with QC Sample Specialists and stability supervisors to correct any discrepancies associated with stability samples for testing

Qualification

HPLCCapillary ElectrophoresisSDS-PAGEICH guidelinesWaters EmpowerChromelenCommunication skillsInterpersonal skills

Required

MS Degree /BS + 1-2 years/No degree + 5 years experience

Educational degrees and experience must be relevant to the position, i.e. college degree with emphasis in a scientific field and/or experience in the regulated pharmaceutical industry in a stability program

An understanding of ICH guidelines and GMP requirements set forth by regulatory agencies associated with the storage of Stability product is required

Good communication skills are needed to generate effective written and oral reports that are clear, accurate, and logical

The incumbent must possess excellent interpersonal and communication skills to interact effectively and promptly with all levels of the organization, supporting departmental objectives and management decisions, and maintaining good working relations with multiple cross-functional teams