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Randstad USA · 3 days ago

Sr. Associate Research Scientist II

Triangle, NC

Full-time

Onsite

Mid, Senior Level

$37.50/hr - $43/hr

1+ years exp

Randstad USA is seeking a Sr. Associate Research Scientist II to provide scientific expertise in the research and development of plasma-derived or recombinant proteins while overseeing the daily operations of the Stability Program. The role involves maintaining sample inventory, overseeing stability chamber areas, and ensuring the safety and quality of licensed and developmental products.

ConsultingHuman ResourcesInformation TechnologyRecruiting

H1B Sponsor Likely

Responsibilities

Method Development: Provide technical expertise in R&D utilizing separations-based analytical techniques (HPLC, CE, SDS-PAGE). Develop and qualify methods based on ICH guidelines

Data Management: Utilize Waters Empower (Essential) and Chromeleon to analyze data. Enter test data into stability databases and SAP

Visual Inspection: Perform visual inspection and vial integrity testing on samples

Inventory Control: Maintain daily product inventory for active stability studies. Coordinate with Packaging to acquire batch samples and track requests for additional samples

Sample Management: Maintain and audit sample labeling (Loftware/Intermec printers). Facilitate delivery of samples to laboratories and coordinate with QC Sample Specialists

Chamber Maintenance: Perform daily assessments of stability incubators and freezers. Analyze temperature and humidity trends daily. Generate work orders for preventative maintenance to prevent product loss

Investigations: Conduct investigations for temperature excursions or GMP discrepancies associated with sampling or inventory. Ensure corrective actions (CAPA) are implemented and effective

Documentation: Review monthly pull schedules, ensure compliance of test request sheets, and assist with filing stability records

Regulatory: Maintain strict adherence to cGMP, GLP, and ICH guidelines

Qualification

HPLCCEGMPGLPICHSAPWaters EmpowerChromeleonIndependenceCalculations & DetailCommunication

Required

Master's Degree: In a scientific field

Bachelor's Degree: In a scientific field + 1-2 years of relevant experience

No Degree: 5+ years of relevant experience (specifically for the Associate Stability Research Scientist II level)

Experience must be in the regulated pharmaceutical industry within a stability program

Lab Software: Waters Empower (Essential), Chromeleon (Desirable)

Stability/Logistics Software: ScienTek Stability System, SAP, Loftware labeling solutions, DeltaV Monitoring System, LabWatch, Maximo Management System

Hardware: Intermec printers, TempTale Monitoring Devices

Ability to perform basic calculations and possess keen assessment skills to note uncharacteristic properties of samples

Ability to communicate complex information and apply abstract principles to solve conceptual issues

Ability to carry out tasks independently with minimal supervision

Work is performed in clinical/laboratory settings with potential exposure to biological fluids, infectious organisms, and chemicals

Moderate lifting of 15-30 lbs (max 35 lbs). Frequent sitting, bending neck (4-6 hours), and hand movements for fine manipulation

Color perception/discrimination required. Near/far vision correctable to 20/30 (one eye) and 20/100 (other eye)

Preferred

Chromatography

Laboratory Information Management Systems (LIMS)

High Pressure Liquid Chromatography (HPLC)

Liquid Chromatography (LC)

Good Laboratory Practices (GLP)

Capillary Electrophoresis (CE)

Good Manufacturing Practices (GMP)

International Council for Harmonization (ICH)

Benefits

Medical

Prescription

Dental

Vision

AD&D

Life insurance offerings

Short-term disability

401K plan

Company

Randstad USA

Glassdoor3.8

Randstad US is a wholly owned subsidiary of Randstad Holding nv, a global provider of human resources solutions.

Founded in 1998

Atlanta, Georgia, USA

1001-5000 employees

http://randstadusa.com

H1B Sponsorship

Randstad USA 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)

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