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TalentBurst, an Inc 5000 company · 3 days ago

Associate Stability Research Scientist II

Raleigh, NC

Contract

Onsite

Entry, Mid Level

$40/hr - $41/hr

1+ years exp

TalentBurst, an Inc 5000 company, is seeking an Associate Stability Research Scientist II to provide technical and scientific expertise in the research and development of plasma-derived proteins. The role involves overseeing the stability program, maintaining product inventory, and ensuring compliance with GMP standards.

RecruitingStaffing Agency

Growth Opportunities

H1B Sponsor Likely

Hiring Manager

Himani B.

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

Possess experience necessary to note any uncharacteristic property of the stability samples, as the last viewer of samples before they are sent to the laboratory for testing

Track requests for additional samples

Generate and review monthly pull schedules for all stability testing for all active studies

Generate work orders for preventative maintenance and repairs for all equipment associated with stability incubators to prevent product loss due to equipment failure. Ensure that the Preventative Maintenance program is executed in a timely manner

Assure compliance of all completed test request sheets for stability, as applicable

Experience in conducting a check-in process for receipt of data, when applicable, for data returned from the testing laboratories

Experience with entering test data into the stability databases, Stability System and/or SAP

Assist with filing of all stability records

Conduct investigations to document and resolve GMP discrepancies associated with sampling, labeling, and/or sample inventory

Remove samples from inventory and perform required documentation for completed stability studies

Initiate purchase orders and work orders for the Stability Group

Performs shipment of samples between sites

Trains Stability staff on sample handling and inventory procedures

Perform daily assessments of operation of the stability incubator and freezers

Conduct investigations for any excursions outside validated ranges (temperature for the stability incubators

Analyzes chamber temperature and humidity trends daily to evaluate for any issues. Performs weekly, monthly, and annual reviews to ensure all equipment remaining compliant, and as a preventative measure to address chamber concerns prior to any impact on studies

Qualification

HPLCCapillary ElectrophoresisSDS-PAGEWaters EmpowerICH guidelinesStability SystemSAPLoftware labeling solutionsVisual inspectionVial integrity testingSample handlingInventory procedures

Required

Working knowledge of Waters Empower is essential

Experience necessary to note any uncharacteristic property of the stability samples

Experience in conducting a check-in process for receipt of data, when applicable, for data returned from the testing laboratories

Experience with entering test data into the stability databases, Stability System and/or SAP

Assist with filing of all stability records

Conduct investigations to document and resolve GMP discrepancies associated with sampling, labeling, and/or sample inventory

Remove samples from inventory and perform required documentation for completed stability studies

Initiate purchase orders and work orders for the Stability Group

Performs shipment of samples between sites

Trains Stability staff on sample handling and inventory procedures

Perform daily assessments of operation of the stability incubator and freezers

Conduct investigations for any excursions outside validated ranges (temperature for the stability incubators)

Analyzes chamber temperature and humidity trends daily to evaluate for any issues

Performs weekly, monthly, and annual reviews to ensure all equipment remaining compliant, and as a preventative measure to address chamber concerns prior to any impact on studies

MS Degree /BS + 1-2 years/No degree + 5 years experience (for the Associate Stability Research Scientist II position)

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

Preferred

Proficiency in Chromelen is highly desirable

Experience developing and qualifying methods based on ICH guidelines

Experience with visual inspection and vial integrity testing

Experience with shipment of biological samples

Company

TalentBurst, an Inc 5000 company

Glassdoor4.2

Founded in 2002, TalentBurst is an MBE and JCC certified firm that provides award winning solutions globally.

Founded in 2002

Natick, Massachusetts, USA

1001-5000 employees

http://talentburst.com

H1B Sponsorship

TalentBurst, an Inc 5000 company 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 (3)

2023 (7)

2021 (1)

2020 (4)