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QC Stability Specialist

Woburn, MA 01801

Posted: 02/07/2023 Employment Type: Contract Job Category: Scientific Job Number: 544072 Is job remote?: No Country: United States

Job Description


·       Execute day to day operations of the stability activities through sample receipts, aliquoting, stability sample set-down, data compilation,

·       Responsible for authoring of stability protocols to establishing our Internal stability management capabilities.

·       Provide oversight to CMOs/CTLs to ensure that studies conducted externally are executed compliantly and studies are set down on time

·       Responsible for entering stability data into slide decks, and spreadsheets

·       Responsible for the resolution and on-time completion of stability-related deviations, CAPAs, and Change Controls by providing technical expertise, as appropriate.

·       Responsible for managing the shipment of stability materials to different sites as needed

·       Responsible for generating, updating, and stability-related SOPs, as appropriate.

·       Responsible for ensuring that the stability-related forms / documents adhere to GXP requirements and internal SOPs.

·       Other duties as assigned.


·       2-5 years’ experience in a GxP environment

·       Bachelors in a Life Science

·       Scientific background in Stability or Analytics for Biologics

·       Experience with LIMS preferred

Pay $40-48/hr based on experience
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